Manager, Quality Systems

🏢 Summary: Staff Manufacturing Engineer role focused on developing, validating, and transferring manufacturing processes for a wearable medical device into production. The position drives process improvements, supports production goals, and ensures compliance in a regulated medical device environment. It involves cross-functional collaboration to implement robust, scalable, and high-quality manufacturing systems. 🗂️ Requirements: B.S. in Mechanical, Biomedical or Industrial Engineering, Minimum 10 years experience in medical device and electro-mechanical manufacturing, Strong SolidWorks proficiency for fixtures, tooling and equipment design, Experience with Lean and Six Sigma methodologies, Proficiency in statistical analysis and root cause investigation, Experience in regulated medical device environments, Expertise in manufacturing processes, automation and materials, Experience with adhesives and electronics 📃 Skills: SolidWorks, SixSigma, Lean, Statistics, Manufacturing, Automation, Electromechanical, Adhesives, Electronics, RootCauseAnalysis, ProcessValidation, Tooling, GD&T 🏢 Description: Element Science, Inc. is a medical device and digital health company redefining how patients with heart disease are monitored and treated as they transition from the hospital to the home. Our mission is to improve outcomes for patients at risk of life-threatening cardiac events through innovative solutions at the intersection of clinical-grade wearables, advanced algorithms, and therapy delivery. We are entering an exciting phase of growth as we move from development into early commercialization. Our approach combines hardware, software, and services to deliver a more personalized and seamless patient experience—designed with both patients and clinicians in mind. Our product, a wearable patch defibrillator, is designed for patients with a temporary elevated risk of sudden cardiac arrest, addressing a significant and underserved population of over 500,000 patients in the U.S. By focusing on comfort, usability, and clinical effectiveness, we aim to transform the standard of care during this critical period. Headquartered in the San Francisco Bay Area, Element Science is backed by leading healthcare and technology investors, including Third Rock Ventures, GV (Google Ventures), Deerfield Healthcare, Qiming Venture Partners USA, Cormorant Asset Management, and Invus Opportunities.SUMMARY OF ROLE: Staff Manufacturing Engineer drives and provides support of products, processes, and equipment to achieve development and/or production goals. The engineer develops manufacturing processes to implement innovative improvements. The engineer works cross-functionally to validate processes and transfer new products into manufacturing. RESPONSIBILITIES: Support process development and validation activities across various manufacturing product lines Design, develop, test and implement manufacturing process systems to ensure robust production processes, human work factors and quality control Design, develop and propose improvements for manufacturing process, equipment and systems using knowledge of engineering principles, industry standards and working design to meet production requirements, performance, quality, and safety standards Employ six sigma tools and scientific and statistical expertise to perform root cause and correlation analysis to identify and develop corrective actions for solving product and process failures Transfer new products & processes into manufacturing, including support of R&D builds Create, update, and maintain manufacturing documentation that meets compliance requirements Partner with outsourced vendors and suppliers to support production and resolve technical issues, working closely with MPI to establish and onboard new vendors Support manufacturing engineering efforts to meet production goals including resolution of non-conformances and line issues Perform other duties, as assigned QUALIFICATIONS: B.S. in Mechanical, Biomedical or Industrial Engineering preferred Comprehensive SolidWorks knowledge with experience creating manufacturing fixtures, tooling, and equipment models Minimum 10 years of experience in medical device industry and electro-mechanical device manufacturing preferred Experience with Lean/Six Sigma tools and proficiency with statistical methodologies preferred Demonstrated technical acumen in navigating regulated environments Excellent interpersonal, writing, and verbal communication skills Demonstrated ability to balance multiple priorities against aggressive deadlines while maintaining a high degree of quality Strong judgment & decision-making ability Excellent problem-solving skills, ability to diagnose issues and provide solutions Experience with adhesives and electronics preferred and background with medical device disposables and capital equipment a plus Strong technical expertise with manufacturing processes, automation, and materials BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The salary for this exempt-level position will be based on experience and qualifications within an established pay range. Pay range: $150,000 - $170,000 Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on full-cycle medical billing and revenue cycle management within the DME/HME industry. The position owns claims submission, AR follow-up, denials and appeals, payment posting, and patient billing support while helping build scalable billing processes. Ideal for an experienced medical billing professional who thrives in a fast-growing environment and can optimize reimbursement operations. 🗂️ Requirements: 3–5+ years medical billing and Revenue Cycle Management experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Strong understanding of HCPCS codes, Strong understanding of ICD-10 coding, Experience with CMNs and Prior Authorizations, Experience with electronic and paper claims submission, Ability to manage denials and appeals, Proficiency in billing systems, Proficiency in CRM systems, Experience with payer portals (e.g., Availity) 📃 Skills: HCPCS, ICD-10, CMN, PriorAuthorization, Medicare, Medicaid, DME, HME, NikoHealth, BrightTree, CRM, Availity, ERAs, EOBs 🏢 Description: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. SUMMARY OF ROLE: This is more than a billing role, it's an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we're looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you'll own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You'll work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The "Startup" Mindset: You are comfortable with ambiguity. You don't just wait for a manual; you help write it. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management within the DME/HME space. The position owns claims submission, AR follow-up, denials and appeals, and payment posting while helping build scalable billing processes during early commercialization. This role combines hands-on reimbursement operations with system optimization and cross-functional collaboration. 🗂️ Requirements: 3–5+ years medical billing and RCM experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Understanding of HCPCS and ICD-10 coding, Experience with CMNs and Prior Authorizations, Ability to manage full-cycle insurance claims and AR follow-up, Proficiency in billing systems (Niko Health or BrightTree preferred), Experience with CRM systems and payer portals (e.g., Availity) 📃 Skills: RCM, DME, HME, HCPCS, ICD-10, CMN, PriorAuthorizations, Medicare, Medicaid, Availity, NikoHealth, BrightTree, CRM 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role, it's an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we're looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you'll own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You'll work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management - Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). - AR Follow-up: Monitor and aggressively pursue unpaid claims. - Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. - Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy - Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. - Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. - Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight - SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. - Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. - System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: - Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. - Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. - Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. - The "Startup" Mindset: You are comfortable with ambiguity. You don't just wait for a manual; you help write it. - Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. - Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity. BENEFITS: Element Science offers a very competitive salary and benefits package including, but not limited to: - Stock Options - 90% employer-paid medical, dental, and vision insurance - Company-paid Basic Life Insurance - 401(k) retirement plan (Traditional and Roth) - Competitive Paid Time Off - Paid Holidays - FSA (Flexible Spending Accounts) - HSA (Health Savings Account) - Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. We do not base our employment decision on an employee's or applicant's race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, or other non-merit-based factors prohibited by local, state, or federal law. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance at Element Science.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management within the DME sector. The position involves owning claims submission, AR follow-up, denials and appeals, patient billing support, and helping build scalable billing processes in a growing commercialization-stage environment. This role combines hands-on reimbursement operations with system optimization and SOP development to support efficient, compliant revenue workflows. 🗂️ Requirements: 3–5+ years of medical billing and Revenue Cycle Management experience, Experience within Durable Medical Equipment (DME) or HME industry, Knowledge of monthly rental billing and capped rental workflows, Strong understanding of HCPCS codes and ICD-10 coding, Experience with CMNs and Prior Authorizations, Experience submitting electronic and paper claims to Medicare, Medicaid, and private payers, Ability to manage denials, appeals, and AR follow-up, Proficiency in billing systems and payer portals, Eligibility to work in the United States without visa sponsorship 📃 Skills: RCM, DME, HCPCS, ICD-10, CMN, PriorAuthorization, Medicare, Medicaid, Niko, BrightTree, CRM, Availity, ERAs, EOBs 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role; it is an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we are looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you will own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You will work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce "days in AR." QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The "Startup" Mindset: You are comfortable with ambiguity and help build processes where none exist. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and payer portals such as Availity. BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO The anticipated salary for this exempt position will be commensurate with experience, qualifications, and market factors and will be aligned with the established compensation range for the role. Element Science is an Equal Opportunity Employer. All candidates will be evaluated on the basis of their qualifications for the job in question. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification form upon hire. We are not able to sponsor individuals for employment visas for this job. At this time, relocation assistance is not offered.

🏢 Summary: Fully remote Accounts Receivable Specialist role focused on end-to-end medical billing and revenue cycle management for a cardiac medical device company. The position owns claims submission, AR follow-up, denials and appeals, payment posting, and patient billing while helping build scalable billing processes. Ideal for an experienced DME billing professional comfortable with payer regulations, coding standards, and billing systems in a high-growth environment. 🗂️ Requirements: 3–5+ years medical billing and RCM experience, Experience in DME or HME industry, Knowledge of monthly rental billing and capped rentals, Understanding of HCPCS and ICD-10 coding, Experience with CMNs and prior authorizations, Ability to manage full-cycle insurance billing and AR, Proficiency in billing systems and payer portals, Eligibility to work in the United States 📃 Skills: HCPCS, ICD-10, CMN, RCM, DME, HME, Niko, BrightTree, CRM, Availity, Medicare, Medicaid 🏢 Description: SUMMARY OF ROLE: Element Science is seeking an Accounts Receivable Specialist to join our growing Revenue Cycle Management team. This is a fully remote position, with a preference for candidates located in the Central Time Zone to support cross-functional collaboration and operational coverage. This is more than a billing role; it is an opportunity to help build a critical function from the ground up. As Element Science continues to scale following commercialization of our innovative cardiac care technology, we are looking for a resourceful, hands-on professional who thrives in fast-paced, high-growth environments and enjoys solving complex problems. In this role, you will own the full lifecycle of claims management while helping design the processes, systems, and infrastructure that will support a world-class reimbursement and billing operation. You will work closely with internal teams and external partners to ensure timely claim resolution, optimize reimbursement outcomes, and contribute to the development of scalable best practices. RESPONSIBILITIES: Full-Cycle Insurance Billing & AR Management Claims Submission: Prepare and submit clean electronic and paper claims to various payers (Medicare, Medicaid, and Private Insurance). AR Follow-up: Monitor and aggressively pursue unpaid claims. Denials & Appeals: Investigate claim denials, gather necessary medical documentation, and draft persuasive appeals to secure reimbursement. Payment Posting: Accurately post insurance payments (ERAs/EOBs), patient payments, and contractual adjustments. Patient Account Management & Advocacy Statement Generation: Oversee the monthly patient billing cycle and ensure statements are accurate and easy to understand. Patient Support: Act as the primary point of contact for inbound calls regarding billing inquiries, insurance coverage, and payment processing. Financial Assistance: Review and process patient financial assistance applications, ensuring compliance with company policy and compassionate communication with those in need. Process Building & Strategic Insight SOP Development: Help create and document standard operating procedures (SOPs) for the billing department. Key Learnings: Identify trends in denials or payer behavior and provide feedback to the clinical and sales teams to improve documentation quality at the source. System Optimization: Assist in refining our billing software workflows to increase efficiency and reduce days in AR. QUALIFICATIONS: Experience: 3–5+ years of experience in medical billing and RCM, specifically within the Durable Medical Equipment (DME) or HME industry. Rental Knowledge: Familiarity with the unique complexities of monthly rental billing, capped rentals, and equipment return workflows. Payer Expertise: Strong understanding of HCPCS codes, ICD-10 coding, CMNs (Certificates of Medical Necessity), and Prior Authorizations. The Startup Mindset: Comfortable with ambiguity and able to help build processes. Communication: Exceptional phone etiquette and the ability to explain complex insurance concepts to patients with empathy and clarity. Tech Savvy: Proficiency in Billing Systems (Niko Health or BrightTree a plus), CRM, and Payer Portals such as Availity. BENEFITS: Stock Options 90% employer-paid medical, dental, and vision insurance Company-paid Basic Life Insurance 401(k) retirement plan (Traditional and Roth) Competitive Paid Time Off Paid Holidays FSA (Flexible Spending Accounts) HSA (Health Savings Account) Employee Assistance Program through PEO In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States. We are not able to sponsor individuals for employment visas for this job. At this time, we are unable to offer relocation assistance.

🏢 Summary: The role leads enterprise engineering strategy for a regulated healthcare platform, overseeing cloud-native systems, mobile products, data architecture, and AI initiatives. It focuses on building scalable, compliant digital solutions that support manufacturing, patient engagement, and prescribing workflows in highly regulated environments. The position also drives AI adoption, operational excellence, and high-performance engineering team leadership. 🗂️ Requirements: Expertise in cloud-native architecture, Experience with mobile platforms, Knowledge of data engineering, Experience deploying AI systems in regulated environments, Understanding of FDA, GxP, DEA, HIPAA, and data governance requirements, Ability to operationalize explainable AI and model governance, Product leadership experience for digital healthcare platforms, Executive-level communication skills, Experience managing technology risk and compliance, Ability to build and scale engineering organizations 📃 Skills: Cloud, Mobile, AI, Data, HIPAA, FDA, GxP, DEA, Analytics, Architecture, Governance, Compliance 🏢 Description: Position Summary: The Director, Engineering is responsible for architecting and scaling a regulated digital ecosystem to support hyper-growth, patient safety, and enterprise velocity. This role owns the digital backbone spanning cloud platforms, mobile products, data, and AI-enabled systems that power manufacturing, quality, patient engagement, and prescribing experiences. Operating at the intersection of technology, regulation, and strategy, the Director translates enterprise priorities into scalable digital platforms that withstand regulatory scrutiny while enabling rapid innovation. Success requires embedding compliance, auditability, and intelligence directly into system design, ensuring digital capabilities compound value over time. This leader defines and executes AI strategy, deploying production-grade, explainable AI in high-stakes environments to automate complexity, improve decision velocity, and elevate outcomes. The role also builds and leads a high-performance digital organization from the ground up, establishing operating rhythms, accountability, and talent density that enable durable execution at global scale. Responsibilities: Enterprise Digital Strategy and Architecture - Define and execute a multi-year digital strategy aligned to enterprise growth, regulatory demands, and AI-enabled scalability. - Architect cloud-native, modular platforms embedding compliance, auditability, and data integrity by design. - Partner with executives to evaluate tradeoffs using system behavior, regulatory risk, and long-term value creation. Product and Mobile Experience Leadership - Own digital product strategy across patient, prescriber, and internal platforms with outcome accountability. - Lead secure, high-performance mobile experiences that personalize care and streamline prescribing workflows. - Establish agile delivery models balancing rapid iteration, quality, and regulatory readiness. Artificial Intelligence and Data Enablement - Define enterprise AI strategy focused on high-impact, regulated use cases across operations and care delivery. - Deploy production-grade, explainable AI systems that perform reliably under regulatory scrutiny. - Build data architectures and analytics foundations enabling predictive insight and decision automation. Regulatory-Native Execution - Embed FDA, GxP, DEA, HIPAA, and data governance requirements into digital systems as core design constraints. - Ensure AI and digital platforms remain auditable, validated, and compliant throughout their lifecycle. - Actively manage technology risk, shutting down or redesigning initiatives that introduce unacceptable exposure. Organization and Operating Rhythm - Design and scale a high-performance digital organization aligned to enterprise priorities. - Attract, develop, and retain top-tier talent while maintaining high performance standards. - Establish operating cadences, metrics, and accountability mechanisms that translate commitments into results. Knowledge and Skills: - Deep expertise in cloud-native architecture, mobile platforms, data engineering, and AI systems deployed in regulated environments with high availability, security, and auditability requirements. - Proven ability to operationalize AI responsibly, including model governance, explainability, bias mitigation, and lifecycle management in high-stakes, compliance-driven settings. - Strong product leadership translating complex clinical, manufacturing, and operational workflows into intuitive, outcome-driven digital experiences. - Executive-level communication and systems thinking, enabling clear tradeoffs, cross-functional alignment, and disciplined execution at enterprise scale. Key Competencies: - Customer Focus: Builds trust through customer-centric solutions. - Strategic AI: Guides responsible AI adoption and adaptation. - Optimizes Work Processes: Drives efficiency with continuous improvement. - Collaborates: Partners effectively to achieve shared goals. - Resourcefulness: Secures and deploys resources efficiently. - Manages Complexity: Simplifies and solves complex challenges. - Ensures Accountability: Delivers on commitments with integrity. - Situational Adaptability: Adjusts approach to shifting conditions. - Communicates Effectively: Tailors messages to diverse audiences. Values: - People: Empowering people defines who we are. - Quality: Excellence in every product, every time. - Service: Serving others is our highest purpose. - Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Physical Requirements: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

🏢 Summary: Quality Control Specialist 503B role focused on ensuring product quality, compliance, and manufacturing continuity in regulated pharmaceutical operations through inspections, testing coordination, deviation management, and documentation. The position uses AI-enabled quality systems, analytics, and automation to improve inspection accuracy, compliance execution, and operational efficiency in a fast-paced environment. 🗂️ Requirements: Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, Quality, Operations, or related field, Minimum 2 years of experience in quality control, manufacturing, laboratory, or regulated operations, Experience with inspections, quality documentation, deviation management, and audit readiness, Knowledge of FDA regulations, cGMP standards, and USP requirements, Proficiency with electronic quality management systems and digital documentation platforms, Ability to manage competing priorities in a fast-paced regulated environment, Strong analytical problem-solving and documentation skills, Ability to collaborate across Manufacturing, QA, Warehouse, and Laboratory teams 📃 Skills: cGMP, FDA, USP, QA, QC, CAPA, Biology, Chemistry, Pharmaceuticals, Analytics, Automation, Documentation, Compliance, Auditing 🏢 Description: POSITION SUMMARY Quality Control Specialist 503B protects product quality, compliance, and manufacturing continuity across 503A and 503B operations through inspection, sampling, testing coordination, and documentation. This role ensures accurate execution, deviation identification, and data integrity supporting patient safety and operational reliability. Leveraging AI-enabled quality systems, analytics, and automation, the position improves review speed, inspection accuracy, and decision-making. Success requires execution rigor, learning agility, and disciplined problem solving within a highly regulated, fast-paced environment. RESPONSIBILITIES Quality Operations - Performs material inspections, sampling, and quality verification supporting compliant manufacturing and product release. - Utilizes AI-enabled systems and workflows to improve inspection accuracy, processing speed, and documentation quality. - Coordinates sample management, testing activities, and laboratory communication supporting product quality and operational continuity. - Leverages AI-assisted analytics and digital systems to improve visibility, reduce delays, and strengthen compliance execution. - Drafts nonconformance investigations and assists in investigations, impact assessments, deviation tracking, CAPA, and change control activities. - Applies AI-powered analytics to identify trends, improve responsiveness, and strengthen root cause visibility. Compliance And Documentation - Maintains accurate, audit-ready records supporting cGMP compliance and manufacturing continuity. - Uses digital systems and AI-assisted tools to improve data integrity, reduce errors, and strengthen process consistency. - Executes quality activities aligned with FDA, USP, and company procedures supporting safe manufacturing operations. - Supports audits and inspections through organized documentation and adherence to procedures. - Uses AI-powered reporting tools to improve preparedness and compliance responsiveness. Continuous Improvement - Identifies opportunities to improve workflows, documentation, and inspection processes. - Uses AI-driven analytics and automation to improve efficiency, compliance, and operational performance. - Collaborates with Manufacturing, QA, Warehouse, and Laboratory teams to resolve issues and support operations. - Expands expertise in quality systems and regulatory standards while leveraging AI tools to improve performance and adaptability. KNOWLEDGE AND SKILLS - Strong understanding of quality control processes, cGMP documentation practices, inspection procedures, deviation management, and compliance standards. - Proficiency using electronic quality management systems, digital documentation platforms, AI-enabled analytics tools, and automated workflows. - Demonstrated analytical problem-solving capabilities with experience identifying quality risks, supporting investigations, improving documentation accuracy, and managing competing priorities. - Excellent communication, collaboration, and organizational skills. EXPERIENCE AND QUALIFICATIONS - Bachelor's degree in Biology, Chemistry, Quality, Pharmaceutical Sciences, Operations, or related discipline preferred. - Minimum 2 years of quality control, manufacturing, laboratory, or regulated operational experience preferred. - Experience supporting inspections, quality documentation, deviation management, audit readiness, and electronic quality systems strongly preferred. - Familiarity with FDA regulations, cGMP standards, USP requirements, AI-enabled quality technologies, and digital workflow platforms preferred. - Demonstrated ability to execute with precision, adapt rapidly to changing operational demands, and contribute effectively within collaborative teams. Key Competencies - Customer Focus - Strategic AI - Optimizes Work Processes - Collaborates - Resourcefulness - Manages Complexity - Ensures Accountability - Situational Adaptability - Communicates Effectively Values - People - Quality - Service - Innovation Employee Benefits, Health and Wellness - Medical, dental, and vision coverage - Paid time off - 401(k) matching - Wellness perks - IV therapy - Compounded medications Physical Requirements - Ability to remain in a stationary position for significant periods. - Frequent use of hands and fingers to access and retrieve information from computers and office devices. - Regular standing, walking, reaching, balancing, stooping, kneeling, crouching, or crawling.

🏢 Summary: Buyer Planner II supports procurement, inventory planning, and supplier coordination for regulated pharmaceutical manufacturing operations. The role focuses on maintaining material availability, optimizing supply chain performance, and improving operational efficiency using AI-enabled forecasting, ERP systems, and procurement analytics tools. Candidates should have experience in purchasing or supply chain operations within manufacturing or healthcare environments. 🗂️ Requirements: Bachelor's degree in Supply Chain, Operations, Business Administration, Finance, or related field, Minimum 3 years of purchasing, procurement, inventory planning, or supply chain experience, Experience in manufacturing, healthcare, pharmaceutical, or regulated environments, Proficiency with ERP systems and procurement platforms, Experience with inventory management and forecasting tools, Ability to manage supplier coordination and purchasing operations, Analytical problem-solving and risk management skills, Ability to collaborate across Manufacturing, Planning, Warehouse, Quality, and Finance teams 📃 Skills: ERP, Procurement, Inventory, Forecasting, Analytics, Automation, SupplyChain, Planning, Reporting, AI 🏢 Description: Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, the organization focuses on personalized medicine and pharmaceutical manufacturing. POSITION SUMMARY Buyer Planner II drives material availability, inventory optimization, and supply continuity supporting expanding 503A and 503B operations. This role owns purchasing execution, demand alignment, supplier coordination, inventory planning, and operational responsiveness ensuring uninterrupted manufacturing, service reliability, and scalable business growth. Leveraging AI-enabled forecasting, inventory analytics, workflow automation, and procurement insights, the position improves decision-making speed, purchasing accuracy, operational visibility, and supply chain efficiency across regulated environments. RESPONSIBILITIES Procurement Operations - Execute purchasing activities, supplier coordination, purchase order management, and material tracking supporting uninterrupted manufacturing operations and inventory availability. - Utilize AI-enabled forecasting, workflow automation, and procurement analytics tools to improve purchasing accuracy and accelerate transaction processing. - Manage inventory replenishment activities, demand alignment, and planning coordination supporting operational continuity and production schedules. - Apply AI-assisted forecasting, inventory analytics, and digital planning tools to reduce shortages and improve material availability. - Partner with suppliers, warehouse teams, manufacturing operations, and planning stakeholders to maintain supply continuity and resolve material challenges proactively. Operational Excellence - Identify supplier risks, inventory vulnerabilities, and operational disruptions impacting manufacturing continuity, customer service, or procurement performance. - Utilize AI-enabled analytics, predictive insights, and trend monitoring tools to strengthen contingency planning and reduce operational interruptions. - Evaluate procurement workflows, purchasing activities, and operational processes to identify opportunities improving efficiency and scalability. - Apply AI-powered automation, digital procurement systems, and continuous improvement methodologies to reduce inefficiencies and enhance workflow consistency. - Maintain accurate purchasing records, inventory data, supplier documentation, and operational reporting supporting compliance alignment and reliable decision-making. Cross Functional Collaboration - Collaborate with Manufacturing, Planning, Warehouse, Quality, and Finance teams to support operational priorities and procurement responsiveness. - Support production schedules, inventory planning initiatives, and supply chain priorities ensuring timely material availability. - Expand procurement, planning, and operational expertise through training, technology adoption, and process improvement participation. KNOWLEDGE AND SKILLS - Strong understanding of purchasing operations, inventory planning, supplier coordination, procurement workflows, and supply chain processes. - Proficiency using ERP systems, procurement platforms, AI-enabled forecasting tools, inventory analytics technologies, and operational dashboards. - Demonstrated analytical problem-solving capabilities with experience identifying inventory risks and improving purchasing efficiency. - Excellent communication, collaboration, and organizational skills. EXPERIENCE AND QUALIFICATIONS - Bachelor's degree in Supply Chain, Operations, Business Administration, Finance, or related discipline preferred. - Minimum 3 years of purchasing, procurement, inventory planning, supply chain, or buyer planner experience preferred. - Experience utilizing ERP systems, procurement platforms, inventory management tools, forecasting technologies, and operational reporting systems strongly preferred. - Familiarity with AI-enabled procurement analytics, workflow automation tools, and digital planning methodologies preferred. - Demonstrated ability to execute with precision, adapt quickly to operational change, and contribute effectively within collaborative teams. EMPLOYEE BENEFITS, HEALTH AND WELLNESS Comprehensive benefits include medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. PHYSICAL REQUIREMENTS The employee is required to communicate effectively, remain in a stationary position for extended periods, frequently use hands and fingers to operate office equipment, and regularly move throughout the office and corporate campus. The role may require standing, walking, reaching, climbing, balancing, stooping, kneeling, crouching, or crawling.

🏢 Summary: Quality Operations Specialist role focused on ensuring compliant sterile and non-sterile pharmaceutical manufacturing in a 503A/503B environment through batch review, deviation management, root cause analysis, and quality oversight. The position supports regulatory compliance, environmental monitoring, and operational efficiency while leveraging AI-enabled tools to improve quality processes and decision-making. 🗂️ Requirements: Bachelor of Science in a science-related discipline, Minimum 4 years of directly related experience, Experience in sterile and non-sterile manufacturing, Knowledge of cGMP regulations, Knowledge of state and federal regulations, Proficiency in data analysis, Experience with root cause analysis and CAPA processes, Proficiency in Microsoft Office, Strong organizational and prioritization skills 📃 Skills: cGMP, CAPA, FDA, Excel, Word, PowerPoint, Outlook, AI, Manufacturing, Compliance, Aseptic, Cleanroom, Monitoring, Analysis 🏢 Description: Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing. We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we've created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that's transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let's transform healthcare together.Position Summary: The Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing. This role owns quality oversight across manufacturing review, deviation management, and compliance assurance within a fast-scaling 503A/503B environment. Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale. Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes. Responsibilities: Quality Execution Batch Review: Conduct detailed review of cGMP batch records and manufacturing documentation, using AI-enabled validation tools to identify discrepancies, improve accuracy, and accelerate throughput. Process Monitoring: Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures. Release Support: Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards. Deviation and Investigation Deviation Handling: Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements. Root Cause Analysis: Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions. CAPA Support: Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure. Compliance and Efficiency Regulatory Adherence: Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment. Environmental Monitoring: Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards. Operational Support: Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution. Knowledge and Skills: Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems. Proficiency in data analysis, root cause investigation methodologies, and CAPA processes. Strong organizational, prioritization, and multitasking skills in fast-paced, regulated environments. Effective communication and cross-functional collaboration skills. Experience and Qualifications: Minimum of 4 years of directly related experience. Bachelor of Science in a science-related discipline required. Strong attention to detail, organizational, and prioritization skills. Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Outlook. Experience in sterile and non-sterile manufacturing and knowledge of state and federal regulations required. Key Competencies: Customer Focus: Builds trust through customer-centric solutions. Strategic AI: Guides responsible AI adoption and adaptation. Optimizes Work Processes: Drives efficiency with continuous improvement. Collaborates: Partners effectively to achieve shared goals. Resourcefulness: Secures and deploys resources efficiently. Manages Complexity: Simplifies and solves complex challenges. Ensures Accountability: Delivers on commitments with integrity. Situational Adaptability: Adjusts approach to shifting conditions. Communicates Effectively: Tailors messages to diverse audiences. Values: People: Empowering people defines who we are. Quality: Excellence in every product, every time. Service: Serving others is our highest purpose. Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Physical Requirements: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.

🏢 Summary: Quality Operations Specialist role focused on ensuring compliant sterile and non-sterile pharmaceutical manufacturing within a 503A/503B environment. The position supports batch review, deviation management, root cause analysis, CAPA processes, and environmental monitoring while leveraging AI-enabled tools to improve quality operations. Candidates are expected to work cross-functionally to maintain regulatory compliance and optimize operational efficiency. 🗂️ Requirements: Bachelor of Science in a science-related discipline, Minimum 4 years of directly related experience, Knowledge of cGMP regulations, Experience in sterile manufacturing, Experience in non-sterile manufacturing, Knowledge of state and federal pharmaceutical regulations, Proficiency in data analysis, Experience with root cause analysis methodologies, Experience with CAPA processes, Proficiency in Microsoft Office, Strong organizational and prioritization skills 📃 Skills: cGMP, CAPA, FDA, Excel, Word, PowerPoint, Outlook, AI, Manufacturing, Compliance, Aseptic, Cleanroom, Monitoring, Analysis 🏢 Description: Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide. As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing. We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc. 5000 List for 2025. Our strength is built on four core values: People, Quality, Service, and Innovation. Guided by these principles, we've created a uniquely integrated healthcare platform powered by advanced technology, operational excellence, and a relentless commitment to patient care. From manufacturing and quality control to distribution and customer experience, our teams work together to raise industry standards, expand access to critical medications, and improve outcomes for patients and providers across the country. At Empower, joining our team means more than starting a new role. It means becoming part of a mission-driven organization that's transforming healthcare at scale. We invest deeply in our people, encourage bold thinking, and create opportunities for growth, leadership, and innovation at every level. Your ideas matter here, your development is supported, and the work you do has a direct impact on the lives of millions. If you thrive in a fast-moving, purpose-driven environment where innovation, collaboration, and ambition come together, Empower Pharmacy is the place for you. Let's transform healthcare together.Position Summary: The Quality Operations Specialist ensures consistent delivery of safe, sterile, and compliant pharmaceutical products, directly impacting patient outcomes and regulatory standing. This role owns quality oversight across manufacturing review, deviation management, and compliance assurance within a fast-scaling 503A/503B environment. Leveraging AI as a force multiplier, the Specialist enhances review speed, improves deviation detection, strengthens root cause analysis, and enables data-driven decision-making at scale. Operating with high autonomy, this role integrates quality into operational execution while continuously improving systems and processes. Responsibilities: Quality Execution Batch Review: Conduct detailed review of cGMP batch records and manufacturing documentation, using AI-enabled validation tools to identify discrepancies, improve accuracy, and accelerate throughput. Process Monitoring: Monitor manufacturing activities to ensure adherence to aseptic techniques, cleanroom standards, and operational procedures. Release Support: Support product release readiness by verifying data integrity and completeness while ensuring alignment with regulatory expectations and quality standards. Deviation and Investigation Deviation Handling: Identify, document, and support triage of deviations, ensuring timely escalation and compliance with internal procedures and regulatory requirements. Root Cause Analysis: Perform structured root cause analysis using data-driven methodologies to uncover underlying issues and support effective corrective actions. CAPA Support: Assist in the development and implementation of corrective and preventive actions, tracking effectiveness and closure. Compliance and Efficiency Regulatory Adherence: Execute quality processes in alignment with FDA and state regulations within a 503A/503B environment. Environmental Monitoring: Perform and support environmental monitoring activities to ensure compliance with sterility and contamination control standards. Operational Support: Collaborate with cross-functional teams to resolve quality issues, improve workflows, and support high-quality execution. Knowledge and Skills: Strong knowledge of cGMP regulations, sterile and non-sterile manufacturing processes, and quality systems. Proficiency in data analysis, root cause investigation methodologies, and CAPA processes. Strong organizational, prioritization, and multitasking skills in fast-paced, regulated environments. Effective communication and cross-functional collaboration skills. Experience and Qualifications: Minimum of 4 years of directly related experience. Bachelor of Science in a science-related discipline required. Strong attention to detail, organizational, and prioritization skills. Proficiency in Microsoft Office, including Excel, Word, PowerPoint, and Outlook. Experience in sterile and non-sterile manufacturing and knowledge of state and federal regulations required. Key Competencies: Customer Focus: Builds trust through customer-centric solutions. Strategic AI: Guides responsible AI adoption and adaptation. Optimizes Work Processes: Drives efficiency with continuous improvement. Collaborates: Partners effectively to achieve shared goals. Resourcefulness: Secures and deploys resources efficiently. Manages Complexity: Simplifies and solves complex challenges. Ensures Accountability: Delivers on commitments with integrity. Situational Adaptability: Adjusts approach to shifting conditions. Communicates Effectively: Tailors messages to diverse audiences. Values: People: Empowering people defines who we are. Quality: Excellence in every product, every time. Service: Serving others is our highest purpose. Innovation: Advancing care through technology and discovery. Employee Benefits, Health and Wellness: We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications. Learn more: https://careers.empowerpharmacy.com/benefits/ Physical Requirements: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. Employees are regularly required to move about the office and around the corporate campus. The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.