Quality Control Specialist

🏢 Summary: Quality Control Specialist role in a medical device manufacturing environment focused on receiving, in-process, and final inspections for catheter-based cardiovascular products. The position supports quality systems, nonconforming product reviews, equipment calibration, environmental monitoring, and lot release activities in an in-office setting. The offer includes competitive pay, equity opportunities, comprehensive benefits, and professional growth during company expansion. 🗂️ Requirements: High school diploma or equivalent, 2+ years of hands-on quality inspection experience in medical device manufacturing, Proficiency with word processing software, Proficiency with spreadsheet software, Full professional proficiency in English, Experience performing receiving, in-process, and final inspections, Ability to document nonconforming products, Ability to maintain traceability and quality system records 📃 Skills: QC, Inspection, Calibration, Monitoring, NCR, NCMR, CAPA, Traceability, Sampling, Microscopes, Excel, Word 🏢 Description: Company Summary: Join a team that's redefining what's possible in cardiovascular treatment. At Jupiter Endovascular, we're revolutionizing catheter-based therapies by bringing the precision and control of surgery to minimally invasive procedures. For decades, catheters have remained largely unchanged—rigid, unstable, and difficult to maneuver through the body's winding anatomy. We've developed a transforming fixation technology that navigates flexibly through the vascular system, then locks into place to deliver treatment with surgical-like stability and control. Our device solves one of the longest-standing challenges in endovascular procedures, empowering physicians and improving outcomes for millions of patients living with cardiovascular disease. We're entering an exciting new phase—scaling up production, expanding our team, and preparing for commercial launch. Founded and headquartered in Menlo Park, California, Jupiter Endovascular is led by a proven team of medical device entrepreneurs and backed by top-tier investors across venture capital, private equity, and strategic partners. We've built a fast-paced, collaborative culture grounded in innovation, teamwork, and purpose. Every role at Jupiter directly contributes to our mission: saving lives by advancing the future of endovascular therapy. Position Overview: The Quality Control Specialist is primarily responsible for receiving, in-process, and final product inspections. The QC Specialist may also perform equipment calibration and maintenance coordination and environmental monitoring activities in accordance with established quality system procedures. This role also supports nonconforming product disposition, traceability, lot release, and other quality assurance activities as assigned. This is an in-office role. Responsibilities: - Perform product receiving, in-process, and final inspections in accordance with written procedures, statistical sampling plans, engineering drawings, and product specifications, documenting nonconforming products as appropriate. - May administer the equipment calibration and maintenance system, environmental monitoring program, and bioburden monitoring program, including coordination with subcontracted service providers. - Coordinate or lead nonconforming product reviews, including Material Review Board activities and NCR/NCMR disposition, to support timely product decisions. - Maintain quality system logs, records, and filing systems, and ensure accurate traceability of components and finished products. - Maintain and operate inspection and test equipment, and provide input on inspection methods and quality procedures. - Support corrective and preventive action activities, supplier evaluations, and supplier performance monitoring. - Review product lot history records and support lot release to finished goods inventory, as applicable. - Support finished goods shipping and commercial release activities, as applicable. - Contribute to improvements in quality system procedures and work instructions related to areas of responsibility. - Train and advise other employees on quality-related requirements and ensure effective communication across functions. - Represent areas of responsibility during internal and external quality audits and support audit readiness. Qualifications: - High school diploma or equivalent required. - Minimum of two years of experience with hands on quality inspection in a medical device manufacturing environment required. - Startup or small-company experience preferred. - Catheter manufacturing experience preferred. - Proficiency with word processing and spreadsheet software required. - Full professional proficiency in English required. Preferred Qualifications: - Experience reading and interpreting engineering drawings, specifications, and statistical sampling plans. - Experience using dimensional and visual inspection equipment, including microscopes. - Strong hand-eye coordination, manual dexterity, color vision, and visual acuity, corrected if necessary. - Ability to work under pressure, manage multiple deadlines, and maintain effective working relationships. - Strong attention to detail, organizational skills, and oral and written communication skills. Why Jupiter Endovascular? - Work in a culture built on shared purpose, where passionate teammates support one another and stay motivated by improving patient lives. - Thrive in a collaborative environment that values new ideas, gives everyone a voice, and offers professional growth and exposure across departments as the company enters an exciting phase of expansion. - Earn competitive pay with performance incentives and equity opportunities. - Enjoy comprehensive, top of the market medical, dental, and vision coverage focused on meaningful premium support and smart savings. - Access meaningful benefits including a top tier 401(k) with a best in-class plan design which includes strong employer contributions, short and long-term disability, life insurance, commuter benefits, and wellness support. - Take advantage of a healthy paid time off policy, company holidays, and an environment that encourages a healthy work-life balance. - Strengthen relationships through shared experiences - from daily company-provided lunches and Thursday socials to monthly potlucks, company events, and volunteer opportunities that have a real impact in the community. Compensation: The starting base pay for this role is between $30-$40/hr. The actual base pay is dependent upon many factors, such as training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits, and 401(k) with matching. Jupiter Endovascular provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

🏢 Summary: Quality Control Specialist role focused on receiving, in-process, and final inspections for medical devices in a fast-paced manufacturing environment. The position supports quality assurance activities including calibration, environmental monitoring, nonconforming product review, traceability, and lot release. This is an in-office role with opportunities to contribute to quality system improvements and audit readiness. 🗂️ Requirements: High school diploma or equivalent, 2+ years of hands-on quality inspection experience in medical device manufacturing, Proficiency with word processing software, Proficiency with spreadsheet software, Professional proficiency in English, Ability to perform receiving, in-process, and final inspections, Experience documenting nonconforming products, Ability to maintain traceability and quality records 📃 Skills: QC, Inspection, Calibration, Monitoring, NCR, NCMR, Traceability, Sampling, Microscopes, Excel, Word, Audit, CAPA, Bioburden 🏢 Description: Company Summary: Join a team that's redefining what's possible in cardiovascular treatment. The company is revolutionizing catheter-based therapies by bringing the precision and control of surgery to minimally invasive procedures. Their transforming fixation technology navigates flexibly through the vascular system, then locks into place to deliver treatment with surgical-like stability and control. The device addresses longstanding challenges in endovascular procedures, improving physician control and patient outcomes. The company is scaling production, expanding the team, and preparing for commercial launch. Position Overview: The Quality Control Specialist is primarily responsible for receiving, in-process, and final product inspections. The QC Specialist may also perform equipment calibration and maintenance coordination and environmental monitoring activities in accordance with established quality system procedures. This role also supports nonconforming product disposition, traceability, lot release, and other quality assurance activities as assigned. This is an in-office role. Responsibilities: - Perform product receiving, in-process, and final inspections in accordance with written procedures, statistical sampling plans, engineering drawings, and product specifications, documenting nonconforming products as appropriate. - Administer equipment calibration and maintenance systems, environmental monitoring programs, and bioburden monitoring programs, including coordination with subcontracted service providers. - Coordinate or lead nonconforming product reviews, including Material Review Board activities and NCR/NCMR disposition, to support timely product decisions. - Maintain quality system logs, records, and filing systems, and ensure accurate traceability of components and finished products. - Maintain and operate inspection and test equipment, and provide input on inspection methods and quality procedures. - Support corrective and preventive action activities, supplier evaluations, and supplier performance monitoring. - Review product lot history records and support lot release to finished goods inventory. - Support finished goods shipping and commercial release activities. - Contribute to improvements in quality system procedures and work instructions related to areas of responsibility. - Train and advise other employees on quality-related requirements and ensure effective communication across functions. - Represent areas of responsibility during internal and external quality audits and support audit readiness. Qualifications: - High school diploma or equivalent required. - Minimum of two years of experience with hands-on quality inspection in a medical device manufacturing environment required. - Startup or small-company experience preferred. - Catheter manufacturing experience preferred. - Proficiency with word processing and spreadsheet software required. - Full professional proficiency in English required. Preferred Qualifications: - Experience reading and interpreting engineering drawings, specifications, and statistical sampling plans. - Experience using dimensional and visual inspection equipment, including microscopes. - Strong hand-eye coordination, manual dexterity, color vision, and visual acuity, corrected if necessary. - Ability to work under pressure, manage multiple deadlines, and maintain effective working relationships. - Strong attention to detail, organizational skills, and oral and written communication skills. Benefits: - Collaborative and mission-driven work environment. - Professional growth opportunities and cross-functional exposure. - Competitive pay with performance incentives and equity opportunities. - Comprehensive medical, dental, and vision coverage. - 401(k) with employer contributions. - Short and long-term disability coverage and life insurance. - Commuter benefits and wellness support. - Paid time off and company holidays. - Company lunches, social events, potlucks, and volunteer opportunities. Compensation: The starting base pay for this role is between $30-$40/hr depending on experience, skills, business needs, and location. The role may also be eligible for equity, benefits, and 401(k) matching.

🏢 Summary: The offer is for a Quality Systems Specialist role focused on developing and maintaining a Healthcare Quality Management System for medical software products classified as Software as a Medical Device. The position involves ensuring regulatory compliance for EU and US markets, supporting audits, documentation, and quality processes across the full software lifecycle. The role emphasizes continuous improvement and alignment with medical device standards. 🗂️ Requirements: Minimum 3 years experience with medical device quality systems, Practical experience with ISO 13485, Practical experience with ISO 14971, Degree in engineering, medical technology, life sciences or related field, Experience with structured documentation in regulated environments, Ability to coordinate with multiple stakeholders, Strong analytical and documentation skills, Professional proficiency in English 📃 Skills: ISO13485, ISO14971, IEC62304, Agile, QMS, Audit, RegulatoryCompliance, Documentation, Validation 🏢 Description: Project overview You will be involved in the development and maintenance of a Healthcare Quality Management System that supports multiple medical software products delivered to international markets. The project focuses on aligning software engineering practices with medical device regulations and quality standards. Position overview We are looking for a Quality Systems Specialist who will contribute to building and maintaining quality systems for medical software products classified as Software as a Medical Device. You will work on regulatory compliant digital health solutions intended for the EU and US markets, focusing on quality processes, documentation, audits, and continuous improvement across the full software lifecycle. Responsibilities Maintain and support the Healthcare Quality Management System and its ongoing certification activities. Support preparation for and participation in external audits, including evidence collection and audit coordination. Provide quality support to medical software projects throughout planning, development, release, and maintenance phases. Prepare and execute internal audits, including audit planning, documentation, reporting, and follow up actions. Support coordination and tracking of corrective and preventive actions. Collaborate with engineering, legal, compliance, and other internal teams on quality and regulatory topics. Participate in customer audits and supplier evaluations within the scope of assigned projects. Contribute to continuous improvement initiatives and systemic quality enhancements. Support validation activities for quality management and documentation tools. Promote quality awareness by delivering internal workshops and training sessions. Requirements At least three years of experience working with medical device quality systems. Practical experience with ISO 13485 and ISO 14971. A degree in engineering, medical technology, life sciences, or a comparable field. Experience working with structured documentation and regulated processes. Ability to work independently while coordinating effectively with multiple stakeholders. Strong analytical, documentation, and written communication skills. Professional working proficiency in English. Interest in developing skills in regulatory affairs for medical software. Nice to have Experience participating in or conducting audits. Exposure to IEC 62304 or other medical software lifecycle standards. Understanding of Agile software development practices. Initial experience with EU or US medical device regulatory frameworks. What We Offer: Vacation days : Up to 26 business days per year. 10 illness/special days off per year (fully paid, no medical papers needed) for all contract types Health and life insurance (Luxmed) MyBenefit platform with Multisport option Internal psychological support service English language classes from the first working day Access to external learning platforms : O’Reilly, LinkedIn Learning, Udemy, and a wide catalog of diverse internal training Flexible workplace : work from the office, from home, or choose a hybrid option Tech Skills Mentoring Program Opportunities to develop as a public speaker, mentor, or technical interviewer Fully paid idle (bench) when not involved in a project Certification reimbursement (AWS, GCP, Microsoft, etc.)

🏢 Summary: The Manager, Quality Systems leads and continuously improves the Quality Management System for a medical device company, ensuring compliance with FDA, ISO 13485, EU MDR, CHAP, and DME requirements. The role oversees document control, CAPA, nonconformance, audits, training, and regulatory activities while serving as deputy management representative during inspections. This position drives audit readiness, regulatory compliance, and cross-functional quality initiatives in a regulated manufacturing environment. 🗂️ Requirements: 5+ years Quality Assurance experience in medical device industry, 2+ years people management experience, Knowledge of ISO 13485, Knowledge of 21 CFR Part 820, Knowledge of FDA Quality System Regulations, Knowledge of EU MDR requirements, Experience in regulated manufacturing environments, Experience with eQMS systems, Experience with PLM systems, Experience managing CAPA and nonconformance processes, Experience conducting internal and external audits, Experience working with regulatory agencies (FDA, BSI, CHAP), Ability to manage DME compliance requirements 📃 Skills: ISO13485, 21CFR820, FDA, EUMDR, eQMS, PLM, CAPA, Audit, Nonconformance, DME, CHAP, BSI 🏢 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. SUMMARY OF ROLE: The Manager, Quality Systems is responsible for day-to-day operation and continuous improvement of the Quality System. The role is responsible for Document Control, Training Program, Change Control, Internal & External Audit Program, Management Review, Nonconformance management and CAPA management. The Manager, Quality Systems serves as deputy management representative representing the organization in internal and external audits. This role serves as co-system administrator for eQMS and works with cross functional stakeholders ensuring the organization continues to maintain CHAP accreditation and compliance with DME requirements including managing external DME audits, maintaining quality documentation and ensuring adherence to regulatory standards. This role supports EU MDR deliverables in collaboration with external regulatory consultants. This role plays a key part in sustaining a compliant, audit-ready QMS that upholds patient safety and organizational integrity. RESPONSIBILITIES: - Lead, mentor, and develop Quality Systems team members, fostering a culture of quality, accountability, collaboration, and continuous improvement - Partner cross-functionally to investigate quality issues, interpret data trends, and drive timely, risk-based decisions - Build and maintain strong working relationships with internal stakeholders, external auditors, and regulatory partners - Own and maintain the Document Control system, ensuring controlled documents remain accurate, current, compliant, and properly version-controlled - Administer and continuously enhance the company training program, ensuring timely completion, training effectiveness, and maintenance of compliant training records - Own the CAPA program, including driving timely resolution of aging CAPAs, ensuring robust root cause investigations, and monitoring closure effectiveness and metrics - Manage Nonconformance (NC) processes from initiation through final disposition and closure, ensuring timely and compliant execution - Lead Management Review activities, including development of quality metrics, trend analysis, and executive-ready Quality Management Review (QMR) materials - Monitor, analyze, and trend quality system metrics to proactively identify systemic risks, drive corrective actions, and support continuous improvement initiatives - Support post-market surveillance activities, including maintenance of associated documentation and reporting requirements - Support EU MDR compliance activities in partnership with external regulatory consultants, including CERs, PSURs, and PMS deliverables - Maintain quality documentation and records necessary to support BSI certification activities and ongoing CE mark compliance - Own and execute the Internal Audit Program, including audit planning, scheduling, execution, findings management, and verification of corrective action closure - Coordinate CHAP accreditation activities and ongoing DME compliance requirements, including preparation for and management of external audits - Partner with external auditors and regulatory agencies to support inspections, audits, and compliance readiness activities - Ensure the Quality Management System remains compliant with FDA, ISO 13485, CHAP, EU MDR, and other applicable regulatory and quality standards - Support system validation activities, process improvements, and ongoing enhancements to quality systems and tools as needed QUALIFICATIONS: - 5+ years of progressive Quality Assurance experience within the medical device industry, including experience in regulated manufacturing environments - 2+ years of people leadership or management experience, with demonstrated ability to lead and develop high-performing teams - Strong working knowledge of ISO 13485, 21 CFR Part 820, FDA Quality System Regulations, and EU MDR requirements - Hands-on experience utilizing eQMS and PLM systems to support quality and compliance initiatives - Ability to interpret, implement, and adapt to evolving regulatory requirements, including DME quality system standards - Solid understanding of core quality processes, including CAPA, nonconformance management, complaint handling, change control, and internal auditing - Experience partnering with external auditors and regulatory agencies, including BSI, FDA, CHAP, or equivalent organizations - Demonstrated ability to manage multiple priorities and drive execution in a fast-paced, evolving environment - Strong analytical and problem-solving skills, with the ability to identify trends, summarize findings, and communicate recommendations to leadership 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: $144,000 - $154,000 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 non-merit-based factors prohibited by 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: The role focuses on ensuring GxP‑regulated digital systems, particularly LIMS and connected laboratory platforms, remain validated, compliant, and fit for purpose throughout their lifecycle. It combines hands‑on CSV validation, data integrity oversight, and system integration control with product ownership and stakeholder collaboration in Agile/DevOps environments. The position supports global validation, user adoption, and continuous improvement of regulated laboratory systems. 🗂️ Requirements: Bachelor’s or Master’s degree in Computer Science, Engineering or related field, Minimum 5 years of experience in product specialist or validation roles, Strong experience with GxP / CSV validation of laboratory or scientific software, Hands-on experience with ValGenesis and/or Azure DevOps, Knowledge of software development lifecycle in Agile/DevOps environments, Experience with validation lifecycle activities (IQ, OQ, PQ), Understanding of data integrity principles (ALCOA+), Experience validating system integrations and interfaces, Knowledge of role-based access control and electronic records/signatures compliance 📃 Skills: GxP, CSV, LIMS, SDMS, SAP, ValGenesis, Azure, DevOps, ALCOA+, IQ, OQ, PQ, ERP, Agile, RBAC 🏢 Description: At Bayer, we are committed to transparency, equal pay for equal work or work of equal value, and objective reward practices in line with EU and local regulations. The minimum annual gross compensation for this role is 20 240 PLN , with final pay determined based on objective factors such as experience, qualifications, scope of responsibility, and internal alignment. This position is eligible for variable pay components , such as performance‑based bonuses, awarded in accordance with the applicable employee group, role scope, and compensation structure. In addition, Bayer offers a competitive and holistic benefits package, including: - Medical care above statutory requirements - Flexible benefits supporting leisure, and well‑being/sports programs - Life, accident, and disability insurance through group coverage - Employer‑supported pension plans with regular company contributions - Home office allowance to support hybrid or remote work - Extra Paid Holidays Benefits may vary depending on country, role, and employment conditions. For Digital Hub Warsaw, we are looking for: Senior Product Specialist: As a Senior Product Specialist, you will ensure regulated digital products remain compliant, validated, and user-friendly throughout their lifecycle. You will combine GxP validation expertise, product enablement, and stakeholder collaboration to deliver high-quality solutions, particularly across LIMS and connected laboratory systems. YOUR TASKS AND RESPONSIBILITIES Validation & Compliance Lead GxP validation activities across the full system lifecycle (implementation → decommissioning). Plan and oversee IQ/OQ/PQ, ensuring systems remain in a validated state in Agile/DevOps environments. Manage validation deliverables (plans, risk assessments, testing, deviations, change control). Ensure data integrity (ALCOA+), audit trails, e-signatures, and access controls. Validate integrations with LIMS, SDMS, instruments, and ERP/SAP. Act as SME for validation and compliance topics . Product Adoption & Collaboration Drive user adoption through training, communication, and documentation. Align stakeholders across business, quality, and engineering. Coordinate UAT, acceptance criteria, and release readiness. Translate technical and compliance topics for diverse audiences. Use feedback and metrics to improve product performance and user experience . Leadership & Delivery Lead cross-functional initiatives and validation workstreams. Manage timelines, risks, and dependencies. Support continuous improvement and mentor junior team members. WHO YOU ARE: Required Qualifications Bachelor’s or Master’s degree in Computer Science, Engineering, Life Sciences, or related field. 5–7+ years of experience in product specialization, validation, or similar roles in regulated environments. Strong hands-on experience in GxP / CSV validation of scientific or laboratory software. Proven experience with validation tools such as ValGenesis and/or Azure DevOps. Strong understanding of software development lifecycle (SDLC) and Agile/DevOps methodologies. Demonstrated ability to lead cross-functional initiatives and manage complex projects. Excellent communication, stakeholder management, and influencing skills. Preferred Qualifications Experience with LIMS, SDMS, or SAP in regulated laboratory environments. Exposure to product development, backlog management, or product ownership concepts. Formal project management experience or certification. Experience working in global, multi-regional, or multi-platform environments. Ability to influence without formal authority and navigate complex stakeholder landscapes Please send your CV in English.

🏢 Summary: Senior Validation Specialist role focused on leading and coordinating computerized system validation (CSV) activities in a regulated environment. The position involves authoring and reviewing validation documentation, overseeing risk assessments, ensuring audit readiness, and supporting system lifecycle compliance. The role also provides global validation oversight and consultancy across projects and maintenance activities. 🗂️ Requirements: 3+ years experience in IT and Software Validation (CSV, GAMP), Experience in pharma or other regulated environment, Experience leading validation for projects and system maintenance, Experience authoring validation plans, reports and deliverable registries, Experience reviewing validation deliverables and evidences, Knowledge of SDLC processes and models in regulated industry, Experience with CFR 21 Part 11 and Annex 11 compliance, Proficiency in gSuite, Basic knowledge of SAP and MES systems, Hands-on experience with Retina or JIRA, Hands-on experience with ServiceNow, Experience with Lean and/or Agile methodologies, Professional Scrum or SAFe certification (or willingness to obtain), English proficiency at C1 level 📃 Skills: CSV, GAMP, SDLC, CFR21Part11, Annex11, gSuite, SAP, MES, Retina, JIRA, ServiceNow, Lean, Agile, Scrum, SAFe 🏢 Description: As a recruitment company, DCG understands that every business is powered by experienced professionals. Our management style and partnership approach enable us to meet your needs and provide continuous support. Due to our ongoing growth and the large number of recruitment projects we undertake for our partners, we are currently looking for: Senior Validation Specialist Responsibilities: Determines validation approach, identifies deliverables needed or impacted by a project / enhancement / or change for GXP computerized systems Responsible for the review of software documentation according to CSV corporate SOP's, and regulatory guidance Author validation plans/reports, reviews test plans/reports (and other deliverables) to assess and notify that system is ready to go life Lead and author system and functional risk assessments Verification of testing plans, activities, deliverables and records, provide consultancy on test related deviations and corrective actions Assess changes to determine potential impact to the validated state of the computerized system Support system maintenance with validated state and permanent audit readiness Lead and author system periodic review according to procedure Provide input and guidance for a computerized system retirement planning Coordinate and advise on all validation activities on a global level/organizational level for system/project Liaison with business quality/informatics quality to ensure compliance with corporate quality policies and standards Participate actively in validation discussions, provide consultancy for all validation related questions Assures strategic/essential oversight over validation support within the department and provides support/consultancy for the team and within the global organization if necessary Support system audit/inspection preparation and execution as CSV subject matter expert Observe governance processes, escalates area for improvement Prepares recommendations for process optimization in his/her area of influence Requirements: 3+ years experience in IT & Software Validation (CSV, GAMP), preferably in pharma environment Mandatory Experience in Lean and/or Agile approaches Experience in leading validation for projects and systems maintenance Experience in authoring validation plans, reports and deliverable registries Experience in authoring or reviewing validation related deliverables, records and other evidences Experience in software development lifecycle processes (SDLC), models, standards in pharmaceutical industry (or other regulated) Experience in maintenance and support of applications under global inspection agencies, CFR 21 FDA Part 11, Annex 11 Demonstrates proficiency in gSuite Demonstrates basic knowledge of SAP and MES systems and the interfacing thereof Hands-on experience with Retina or JIRA (Backlog Management) Hands-on experience with ServiceNow (Incident, Change, Knowledge Management) Aware of common development technologies and governance processes impacting validation approaches Professional Scrum or SAFe Certification is an advantage (will be mandatory to be obtained within 6 months after joining) Collaborate closely with Product Owner, Scrum Master, Architects, Developers, Business Owners and Tester Team (Leads) Ability to work collaboratively in cross-functional teams to achieve milestones and goals Communication skills, English language mandatory (C1) Demonstrates ability to explain complex concepts with clarity and simplicity Demonstrates strong verbal, written, and interpersonal communication skills Assertiveness, conflict management skills, leadership skills Follow-through and persistence: our team is globally spread and some key stakeholders, due to extremely busy schedules, will need chasing up for input/signatures Ability to share knowledge and guide others Offer: Private medical care Co-financing for the sports card Training & learning opportunities Constant support of dedicated consultant Employee referral program

🏢 Summary: Seeking a Quality Controls Manager to oversee QA/QC processes for industrial construction projects, including inspections, audits, documentation, and continuous improvement initiatives. The role involves developing quality control plans, managing compliance with construction standards, and leading problem-solving efforts to resolve quality issues. Candidates should have extensive industrial construction experience and strong knowledge of construction systems, specifications, and QA/QC tools. 🗂️ Requirements: Bachelor’s degree in construction management, architecture, engineering, or related technical field, 10–15 years of industrial construction or manufacturing experience, Experience developing and implementing Quality Control Inspection Plans, Ability to conduct inspections, audits, and surveillance activities, Experience maintaining QA/QC documentation in Procore, Ability to read and interpret construction specifications and drawings, Knowledge of Division 1–14 CSI master formats, Understanding of commercial construction systems, methods, and materials, Experience with root cause analysis and structured problem-solving, Proficiency with Microsoft Office and estimating/takeoff software, Strong communication skills with architects, engineers, subcontractors, and stakeholders, Ability to work in a fast-paced, high-volume environment 📃 Skills: Procore, Microsoft, WinEst, Timberline, On-Screen, QAQC, CSI, Estimating, Takeoff, Auditing, Inspection, Construction 🏢 Description: Responsibilities: - Develop and implement a project specific Quality Control Inspection Plan (QCIP) - Develop and implementation of activities, including originating objectives, goals and timetables, and implementing new techniques as they become available. - Ensure inspection procedures and requirements are complied with thorough surveillance and witnessed inspection. - Ensure acceptable uniform interpretation of defined technical and quality requirements. - Ensures that Housekeeping and Health & Safety Standards are maintained. - Making sure processes adhere to quality standards - Perform quality audits as required. - Maintain all QAQC related documentation in Procore (inspections, test results, etc.) - Preparing reports by collecting, analyzing and summarizing data - Lead projects with continuous improvement and/or corrective action teams. - Lead structured problem-solving activities to resolve client complaints, audit findings or customer returns in a timely manner that prevents reoccurrence - Participate in construction team meetings for the purposes of issue resolution, continuous improvement opportunities that improve our business and increase client satisfaction - Resolution of client complaints that are quality-related - Provide quality input to site-issued purchase orders or contract bid documents - Monitor/inspect project and construction execution by regular surveillance, inspection and/or formal planned audits - Review and approve contractor quality programs and inspection and test plans submitted as part of their contract requirements; identify appropriate hold or witness points on inspection and test plans. Qualifications: - Bachelor's degree in construction management, architecture, engineering or another technical field. - Minimum three to five (10-15) years' industrial construction or manufacturing experience. - Strong work ethic and a "can-do" attitude. - Ability to solve complex problems and exercise judgment based on the analysis of multiple sources of information - Ability to look beyond the information that has been given, to ask the right questions and work to provide a complete project cost evaluation. - Ability to support and/or lead root cause analysis, disciplined problem-solving and decision-making processes. - Strong communication skills with Architects, Engineers, and Subcontractors. - Effective participation in a team environment, with both internal and external teammates. Technical Requirements: - Knowledge of Division 1 - 14 CSI master formats. - Ability to read and interpret construction specifications and drawings. - Experience with Procore Software - Thorough understanding of commercial construction systems, means and methods. - Ability to communicate effectively with audiences that include management, coworkers, clients, vendors, contractors, and other stakeholders. - Ability to learn and apply knowledge of applicable local, state/province, and federal/national statutes and guidelines. - Must be able to work in a high-volume, fast-paced environment. - Proficient computer skills in Microsoft Office, estimating software (WinEst, Timberline or similar), take-off software (On-Screen Takeoff or similar) - Expertise in construction methods and materials, as it relates to both new construction and tenant improvements/fit outs. - Understanding of trade responsibilities within the overall construction contract.

🏢 Summary: Senior leadership role responsible for building and leading the entire quality and compliance function for pharmaceutical compounding and fulfillment operations. The position oversees regulatory compliance, inspection readiness, quality systems, QA/QC, internal audits, supplier quality, and continuous improvement initiatives. The role requires extensive experience in pharmaceutical quality leadership and deep knowledge of USP standards and regulatory requirements. 🗂️ Requirements: Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field, 10+ years of pharmaceutical quality leadership experience, 5+ years leading quality teams, Strong knowledge of USP <795>, USP <797>, USP <800>, Strong knowledge of cGMP principles, Knowledge of State Board of Pharmacy regulations, Knowledge of DEA compliance requirements, Experience leading regulatory inspections, Experience developing quality systems from the ground up 📃 Skills: USP795, USP797, USP800, cGMP, CAPA, Deviation, ChangeControl, RiskManagement, Audit, QC, QA, DSCSA, FDA, DEA, NABP, OSHA, Lean, SixSigma, Microbiology, StabilityTesting, EnvironmentalMonitoring 🏢 Description: About Us At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience. The Head of Quality & Compliance is a senior leadership position responsible for building and leading a world-class quality organization from the ground up. This role partners across Operations, Production, R&D, Procurement, Engineering, and Executive Leadership to establish a culture of quality, compliance, and continuous improvement across compounding and fulfillment operations. Quality Leadership - Serve as the senior quality leader for all quality-related functions - Develop and execute the organization's quality strategy and roadmap - Establish a culture of quality, accountability, compliance, and continuous improvement - Partner with Operations, Production, R&D, Procurement, Engineering, and Executive Leadership Regulatory Compliance Ensure and maintain ongoing compliance with all applicable regulations and standards, including: - USP <795>, USP <797>, and USP <800> - State Board of Pharmacy and DEA regulations - FDA guidance documents and DSCSA requirements - NABP requirements, OSHA regulations, and Hazardous Drug handling requirements - Maintain inspection readiness at all times Inspection Readiness Program - Develop and lead a formal Inspection Readiness Program with mock inspections - Lead regulatory inspections and manage corrective and preventive actions (CAPAs) - Coordinate responses to State Boards of Pharmacy, NABP, DEA, FDA, and client audits Quality Systems Development Build and maintain comprehensive quality systems including: - CAPA, Deviation, Change Control, Risk Management, and Complaint Programs - Supplier Qualification, Training, and Annual Product Review Programs - Internal Audit, Quality Metrics, Document Control, and Batch Record Review Programs Quality Assurance - Oversee batch record review and release - Manage SOP lifecycle and governance - Approve investigations and CAPAs - Monitor quality trends and KPIs - Review environmental monitoring and facility performance - Lead product quality reviews Quality Control - Build and manage QC laboratories and establish testing programs - Oversee identity testing, potency testing, microbiology, stability, water quality, and environmental monitoring - Manage incoming material qualification Internal Audit Program - Build an internal auditing team and develop annual audit schedules - Conduct facility, process, documentation, vendor, and client audits - Proactively identify compliance gaps before regulatory agencies do Supplier & Vendor Quality - Qualify suppliers and vendors; conduct risk assessments and vendor audits - Oversee quality agreements Training & Development - Develop a comprehensive quality training program for pharmacists, technicians, quality personnel, and operations teams - Ensure competency assessments are completed and documented Continuous Improvement & Team Building - Apply Lean, Six Sigma, and risk-based quality principles to reduce deviations, errors, rework, waste, and complaints - Build and lead Quality Assurance, Quality Control, Internal Audit, Compliance, Document Control, Validation, and Training teams Qualifications Required - Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field - Minimum 10+ years of pharmaceutical quality leadership experience - Minimum 5+ years leading quality teams - Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP principles, State Board of Pharmacy regulations, and DEA compliance - Demonstrated experience leading regulatory inspections and developing quality systems from the ground up Preferred - PharmD, MS, or MBA - Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) - Lean Six Sigma certification - Experience in 503A Compounding, 503B Outsourcing Facilities, Pharmaceutical Manufacturing, or High-Volume Fulfillment Operations Schedule - Full-time, 100% onsite position - Work location: Davie, FL and Miami Gardens, FL (travel between locations as business needs require) - Monday–Friday - Occasional weekend work may be required based on business needs Pay Range $148,000—$182,000 USD Benefits: - 401(k) with up to 4% matching - Medical, dental, vision and life insurance - Paid time off Core Values The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability. Customer-first mindset - develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs Innovation for intervention in care - develop advanced compounding solutions and products to better support patient health outcomes Continuous improvement - continuously improve processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that benefit clients and patients You will play a pivotal role in maintaining these values and contributing to the mission of redefining healthcare delivery through superior pharmacy services. The Pharmacy Hub is an Equal Opportunity Employer. The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role.

🏢 Summary: Senior leadership role responsible for building and leading the entire quality and compliance function for pharmaceutical compounding and fulfillment operations. The position oversees regulatory compliance, inspection readiness, quality systems, QA/QC, internal audits, and supplier quality while partnering cross-functionally to establish a culture of quality and continuous improvement. This onsite role requires extensive pharmaceutical quality leadership experience and deep knowledge of USP standards and regulatory frameworks. 🗂️ Requirements: Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field, Minimum 10+ years of pharmaceutical quality leadership experience, Minimum 5+ years leading quality teams, Strong knowledge of USP <795>, USP <797>, USP <800>, Strong knowledge of cGMP principles, Strong knowledge of State Board of Pharmacy regulations, Strong knowledge of DEA compliance, Experience leading regulatory inspections, Experience developing and implementing quality systems from the ground up, Full-time onsite availability with travel between Davie, FL and Miami Gardens, FL 📃 Skills: USP795, USP797, USP800, cGMP, CAPA, Deviation, ChangeControl, RiskManagement, InternalAudit, QualityControl, QualityAssurance, BatchReview, EnvironmentalMonitoring, Microbiology, StabilityTesting, PotencyTesting, SupplierQualification, DocumentControl, Lean, SixSigma, DSCSA, FDA, DEA, NABP, OSHA 🏢 Description: About Us At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience. The Head of Quality & Compliance is a senior leadership position responsible for building and leading a world-class quality organization from the ground up. This role partners across Operations, Production, R&D, Procurement, Engineering, and Executive Leadership to establish a culture of quality, compliance, and continuous improvement across compounding and fulfillment operations. Quality Leadership Serve as the senior quality leader for all quality-related functions Develop and execute the organization's quality strategy and roadmap Establish a culture of quality, accountability, compliance, and continuous improvement Partner with Operations, Production, R&D, Procurement, Engineering, and Executive Leadership Regulatory Compliance Ensure and maintain ongoing compliance with all applicable regulations and standards, including: USP <795>, USP <797>, and USP <800> State Board of Pharmacy and DEA regulations FDA guidance documents and DSCSA requirements NABP requirements, OSHA regulations, and Hazardous Drug handling requirements Maintain inspection readiness at all times Inspection Readiness Program Develop and lead a formal Inspection Readiness Program with mock inspections Lead regulatory inspections and manage corrective and preventive actions (CAPAs) Coordinate responses to State Boards of Pharmacy, NABP, DEA, FDA, and client audits Quality Systems Development Build and maintain comprehensive quality systems including: CAPA, Deviation, Change Control, Risk Management, and Complaint Programs Supplier Qualification, Training, and Annual Product Review Programs Internal Audit, Quality Metrics, Document Control, and Batch Record Review Programs Quality Assurance Oversee batch record review and release Manage SOP lifecycle and governance Approve investigations and CAPAs Monitor quality trends and KPIs Review environmental monitoring and facility performance Lead product quality reviews Quality Control Build and manage QC laboratories and establish testing programs Oversee identity testing, potency testing, microbiology, stability, water quality, and environmental monitoring Manage incoming material qualification Internal Audit Program Build an internal auditing team and develop annual audit schedules Conduct facility, process, documentation, vendor, and client audits Proactively identify compliance gaps before regulatory agencies do Supplier & Vendor Quality Qualify suppliers and vendors; conduct risk assessments and vendor audits Oversee quality agreements Training & Development Develop a comprehensive quality training program for pharmacists, technicians, quality personnel, and operations teams Ensure competency assessments are completed and documented Continuous Improvement & Team Building Apply Lean, Six Sigma, and risk-based quality principles to reduce deviations, errors, rework, waste, and complaints Build and lead Quality Assurance, Quality Control, Internal Audit, Compliance, Document Control, Validation, and Training teams Qualifications Required Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field Minimum 10+ years of pharmaceutical quality leadership experience Minimum 5+ years leading quality teams Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP principles, State Board of Pharmacy regulations, and DEA compliance Demonstrated experience leading regulatory inspections and developing quality systems from the ground up Preferred PharmD, MS, or MBA Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) Lean Six Sigma certification Experience in 503A Compounding, 503B Outsourcing Facilities, Pharmaceutical Manufacturing, or High-Volume Fulfillment Operations Schedule Full-time, 100% onsite position Work location: Davie, FL and Miami Gardens, FL (travel between locations as business needs require) Monday–Friday Occasional weekend work may be required based on business needs Pay Range $148,000—$182,000 USD Benefits: 401(k) with up to 4% matching Medical, dental, vision and life insurance Paid time off Core Values The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability. Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients. You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services. The Pharmacy Hub is an Equal Opportunity Employer. The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role.

🏢 Summary: Senior leadership role responsible for building and leading the entire Quality & Compliance function across compounding and fulfillment operations, ensuring full regulatory compliance and inspection readiness. The position establishes and oversees comprehensive quality systems, regulatory programs, QC laboratories, and internal audit processes while partnering cross-functionally to drive continuous improvement. This is a full-time onsite role with oversight of quality assurance, quality control, supplier quality, and regulatory inspections. 🗂️ Requirements: Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field, 10+ years of pharmaceutical quality leadership experience, 5+ years leading quality teams, Strong knowledge of USP <795>, USP <797>, USP <800>, Strong knowledge of cGMP principles, Knowledge of State Board of Pharmacy regulations, Knowledge of DEA compliance requirements, Experience leading regulatory inspections, Experience developing quality systems from the ground up 📃 Skills: USP795, USP797, USP800, cGMP, DEA, FDA, DSCSA, NABP, OSHA, CAPA, ChangeControl, RiskManagement, Lean, SixSigma, Microbiology, StabilityTesting, EnvironmentalMonitoring, QualityAssurance, QualityControl, InternalAudit 🏢 Description: About Us At The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience. The Head of Quality & Compliance is a senior leadership position responsible for building and leading a world-class quality organization from the ground up. This role partners across Operations, Production, R&D, Procurement, Engineering, and Executive Leadership to establish a culture of quality, compliance, and continuous improvement across compounding and fulfillment operations. Quality Leadership Serve as the senior quality leader for all quality-related functions Develop and execute the organization's quality strategy and roadmap Establish a culture of quality, accountability, compliance, and continuous improvement Partner with Operations, Production, R&D, Procurement, Engineering, and Executive Leadership Regulatory Compliance Ensure and maintain ongoing compliance with all applicable regulations and standards, including: USP <795>, USP <797>, and USP <800> State Board of Pharmacy and DEA regulations FDA guidance documents and DSCSA requirements NABP requirements, OSHA regulations, and Hazardous Drug handling requirements Maintain inspection readiness at all times Inspection Readiness Program Develop and lead a formal Inspection Readiness Program with mock inspections Lead regulatory inspections and manage corrective and preventive actions (CAPAs) Coordinate responses to State Boards of Pharmacy, NABP, DEA, FDA, and client audits Quality Systems Development Build and maintain comprehensive quality systems including: CAPA, Deviation, Change Control, Risk Management, and Complaint Programs Supplier Qualification, Training, and Annual Product Review Programs Internal Audit, Quality Metrics, Document Control, and Batch Record Review Programs Quality Assurance Oversee batch record review and release Manage SOP lifecycle and governance Approve investigations and CAPAs Monitor quality trends and KPIs Review environmental monitoring and facility performance Lead product quality reviews Quality Control Build and manage QC laboratories and establish testing programs Oversee identity testing, potency testing, microbiology, stability, water quality, and environmental monitoring Manage incoming material qualification Internal Audit Program Build an internal auditing team and develop annual audit schedules Conduct facility, process, documentation, vendor, and client audits Proactively identify compliance gaps before regulatory agencies do Supplier & Vendor Quality Qualify suppliers and vendors; conduct risk assessments and vendor audits Oversee quality agreements Training & Development Develop a comprehensive quality training program for pharmacists, technicians, quality personnel, and operations teams Ensure competency assessments are completed and documented Continuous Improvement & Team Building Apply Lean, Six Sigma, and risk-based quality principles to reduce deviations, errors, rework, waste, and complaints Build and lead Quality Assurance, Quality Control, Internal Audit, Compliance, Document Control, Validation, and Training teams Qualifications Required Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Engineering, or related field Minimum 10+ years of pharmaceutical quality leadership experience Minimum 5+ years leading quality teams Strong knowledge of USP <795>, USP <797>, USP <800>, cGMP principles, State Board of Pharmacy regulations, and DEA compliance Demonstrated experience leading regulatory inspections and developing quality systems from the ground up Preferred PharmD, MS, or MBA Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE) Lean Six Sigma certification Experience in 503A Compounding, 503B Outsourcing Facilities, Pharmaceutical Manufacturing, or High-Volume Fulfillment Operations Schedule Full-time, 100% onsite position Work location: Davie, FL and Miami Gardens, FL (travel between locations as business needs require) Monday–Friday Occasional weekend work may be required based on business needs Pay Range $148,000—$182,000 USD Benefits: 401(k) with up to 4% matching Medical, dental, vision and life insurance Paid time off Core Values The Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability. Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needs Innovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomes Continuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients. You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services. The Pharmacy Hub is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Applicants requiring a reasonable accommodation to participate in the hiring process are encouraged to indicate this in their application. The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role.