Automation Engineer I/II (Contract)

🏢 Summary: Lead the development and validation of IVD reagents and manufacturing processes for molecular diagnostic assays using NGS and cfDNA technologies. The role includes process validation, QC method development, supplier management, and design transfer from R&D to operations in a regulated environment. 🗂️ Requirements: PhD with 8+ years or Master’s with 10+ years in assay/reagent development, 3+ years developing IVD diagnostic tests with NGS cfDNA or multi-omic assay technologies, 2+ years developing reagent specifications and transferring reagent manufacturing processes, Hands-on experience with IVD or LDT reagent development in regulated GxP laboratories, Experience writing protocols, designing experiments, analyzing data, and documenting results, Experience with 21 CFR Part 820 or ISO 13485 compliance, Ability to collaborate across scientific and engineering teams, Experience mentoring and training junior scientists, Ability to work on-site in Palo Alto and travel to reagent manufacturer sites 📃 Skills: NGS, cfDNA, IVD, LDT, GxP, ISO13485, CFR820, MolecularBiology, Biochemistry, Chemistry, Bioinformatics, QC, FMEA, Validation, Multiomics, Immunoassays, Statistics 🏢 Description: DELFI Diagnostics is developing next-generation, blood-based tests that are reliable, accessible and deliver a new way to help detect cancer. Employing advanced machine-learning methods to whole-genome sequencing data, the DELFI platform is built to address high-burden health challenges. The platform relies on fragmentomics and cell-free DNA (cfDNA) analysis to support early cancer detection. FirstLook Lung is a laboratory-developed screening test for individuals eligible for lung cancer screening and can be part of routine blood work. The test uses millions of data points to identify individuals who may have cancer detected through low-dose CT, including early stage disease with a negative predictive value of 99.8 percent. About the role Own the IVD reagent development plan execution by developing reagent specifications and manufacturing processes for finished reagents that will be used for DELFI’s molecular diagnostic assays. Lead the Reagent Development and Operations team and be accountable for Process Validation and Design Transfer from R&D to Operations. Define reagent criticality (Key, Ancillary, General Use) for DELFI's IVD molecular diagnostic assays, and develop reagent FMEA to inform testing rigor and change control requirements. Develop and qualify QC test methods for reagent lot release, including method design, acceptance criteria, lot release procedures, and integration with batch manufacturing records. Evaluate Contract Reagent Manufacturers. Be the primary point of contact and be accountable for the completion of process development and the generation of pilot builds for R&D needs by developing various scopes of work (SOWs) and helping implement supplier agreements. Participate in Quality audits. Plan reagent stability to set preliminary expiry specifications required for Verification and Validation activities. Perform rigorous design of experiment, data analysis, and act as subject matter expert by collaborating with assay biostatisticians, bioinformaticians, engineers, and scientists. Develop IVD design documents required for PMA submission under Design Control to meet product development and project milestones. What you'll bring Required - PhD with 8+ years or Master’s with 10+ years industry assay/reagent development with experience in Molecular Biology, Biochemistry, Chemistry, or a similar discipline - 3+ years of developing IVD diagnostic tests with NGS cfDNA/multi-omic assay technologies from plasma under 21 CFR Part 820 or ISO 13485 - 2+ years of experience developing reagent specifications, reagent integrations with automated platforms, and transferring reagent manufacturing from R&D to internal or external manufacturers - Hands-on reagent development experience for IVD or LDT products in a regulated laboratory environment (GxP) - Experience writing protocols, designing experiments, analyzing, and documenting results in reports - Clear communication skills and experience mentoring and training junior scientists and cross-functional stakeholders - Ability to work on-site at the Palo Alto laboratory three to five days a week with periodic travel for audits Preferred - Experience with IVD reagent kitting and reagent interchangeability - Experience developing reagent QC methods and Process Validation for reagent manufacturing - Experience managing R&D relationships and auditing reagent suppliers

🏢 Summary: Development of software for a high-throughput molecular diagnostics system that detects infectious diseases using multiplex PCR. The role focuses on building and maintaining Java-based applications running on automated laboratory analyzers with robotic cartridge handling. Work involves hybrid collaboration with on-site access to physical diagnostic machines. 🗂️ Requirements: Commercial experience with Java 17, Strong knowledge of Spring v6, Experience with Hibernate v6 or JPA, Experience with SQLite, Experience with Gradle, Experience with Docker, Familiarity with AI agents usage in daily work, Availability for hybrid work in Wrocław with on-site presence when required 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, Gradle, Docker, Swing, Liquibase, AI 🏢 Description: Product: It’s a high-throughput molecular diagnostics system for infectious diseases. Using multiplex PCR (syndromic testing), it can detect multiple pathogens from a single patient sample with minimal hands-on time. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. •   java 17 (critical) •   spring v6 (critical) •   hibernate v6 / jpa (critical) • familiarity with the use of AI agents in everyday work •   sqlite db •   gradle •   swing (big plus) •   docker •   luqibase Work model: hybrid work (Wrocław) . For these projects, you may need to come into the office more frequently. This software runs on physical machines that will only be available in the office, so you may need to be present at a physical workstation during onboarding and when using key features.

🏢 Summary: Development of a high-performance molecular diagnostics system based on multiplex PCR, combining backend services and a Swing-based desktop frontend. The role focuses on building and maintaining a modular, automated analyzer platform with strong emphasis on reliability, performance, and code quality. You will work with a modern Java stack and AI-supported development practices in a high-throughput environment. 🗂️ Requirements: Strong experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with relational databases, Knowledge of SQLite, Understanding of Gradle build processes, Experience with Docker, Experience with Liquibase or similar migration tools, Experience with Swing or desktop application development, Use of AI tools in daily development, Ability to work in high-performance, quality-driven environment 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, SQL, Gradle, Docker, Liquibase, Swing, AI, Copilot, ChatGPT 🏢 Description: Additional information: The project focuses on an advanced molecular diagnostics system for infectious diseases, based on multiplex PCR technology, enabling detection of multiple pathogens from a single sample. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. It operates in a high-throughput environment, requiring strong performance, stability, and high-quality code. The role includes both backend development and contribution to a desktop application frontend. The team works with a modern tech stack and actively leverages AI tools to support daily development work. You’re ideal for this role if you: have strong hands-on experience with Java 17, Spring 6, and Hibernate 6 / JPA have experience working with databases (preferably SQLite) are familiar with Gradle and understand build processes have experience with Docker and containerized environments have worked with Liquibase or similar database migration tools have experience with Swing or are willing to work on desktop applications actively use AI tools (e.g., Copilot, ChatGPT) in your daily development work are comfortable working in a high-performance, quality-driven environment Your day-to-day responsibilities include:​ develop and maintain applications using Java 17 and Spring 6 work on backend components and contribute to the Swing-based frontend integrate with databases and manage schema changes using Liquibase ensure code quality, performance, and system reliability collaborate with the team on designing and implementing new features leverage AI tools to improve development efficiency and solution quality

🏢 Summary: Development of a high-performance molecular diagnostics system based on multiplex PCR, combining backend services and a Swing-based desktop application. The role focuses on building and maintaining a modular, automated analyzer platform with strong emphasis on performance, stability, and code quality. Work involves modern Java technologies, database integration, and containerized environments supported by AI-driven development tools. 🗂️ Requirements: Strong experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with databases (preferably SQLite), Knowledge of Gradle and build processes, Experience with Docker and containerized environments, Experience with Liquibase or similar migration tools, Experience with Swing or desktop application development, Use of AI development tools (e.g., Copilot, ChatGPT), Ability to work in high-performance, quality-driven environment 📃 Skills: Java, Spring, Hibernate, JPA, SQLite, Gradle, Docker, Liquibase, Swing, SQL, Git, AI 🏢 Description: Additional information: The project focuses on an advanced molecular diagnostics system for infectious diseases, based on multiplex PCR technology, enabling detection of multiple pathogens from a single sample. The solution combines ready-to-use assay cartridges with a modular, automated analyzer featuring a touchscreen interface and robotic cartridge handling. It operates in a high-throughput environment, requiring strong performance, stability, and high-quality code. The role includes both backend development and contribution to a desktop application frontend. The team works with a modern tech stack and actively leverages AI tools to support daily development work. You’re ideal for this role if you: have strong hands-on experience with Java 17, Spring 6, and Hibernate 6 / JPA have experience working with databases (preferably SQLite) are familiar with Gradle and understand build processes have experience with Docker and containerized environments have worked with Liquibase or similar database migration tools have experience with Swing or are willing to work on desktop applications actively use AI tools (e.g., Copilot, ChatGPT) in your daily development work are comfortable working in a high-performance, quality-driven environment Your day-to-day responsibilities include:​ develop and maintain applications using Java 17 and Spring 6 work on backend components and contribute to the Swing-based frontend integrate with databases and manage schema changes using Liquibase ensure code quality, performance, and system reliability collaborate with the team on designing and implementing new features leverage AI tools to improve development efficiency and solution quality

🏢 Summary: The offer is for an experienced Manual Tester to work on complex systems related to genetic and molecular diagnostics, focusing on embedded and system-level software. The role involves designing and executing manual tests, analyzing requirements, and ensuring high quality in an Agile international environment. It is an on-site B2B position in Wrocław with collaboration across cross-functional teams. 🗂️ Requirements: Minimum 5 years of experience in software testing, Hands-on experience in manual testing of complex systems, Experience with embedded or system-level software testing, Strong experience in test design and execution, Experience in creating and maintaining test documentation, Experience in requirements analysis (SRS, SDS), Ability to plan effective test coverage, Experience in defect identification and bug reporting, Experience working in Agile/Scrum environment, Proficiency in English at minimum B2 level, Experience with JIRA, Confluence, MS Teams, Office 365 📃 Skills: ManualTesting, EmbeddedSystems, SystemTesting, TestDesign, TestExecution, TestDocumentation, RequirementsAnalysis, TestCoverage, DefectTracking, JIRA, Confluence, MSTeams, Office365, Agile, Scrum 🏢 Description: For our client we are currently looking for a Manual Tester who, together with the team, will be responsible for the technical aspects of the project related to genetic diagnostics. In this position, you will collaborate with international teams and contribute to projects in the field of biotechnology and molecular diagnostics. Key responsibilities Performing manual testing of complex systems, including embedded and system-level software Creating, maintaining, and executing test cases, test scenarios, and test documentation Analyzing requirements and specifications (SRS, SDS) and translating them into effective test coverage Identifying defects, reporting bugs, and supporting their resolution Implementing and adapting test strategies depending on project needs Participating in quality assurance processes and continuous improvement Working in an Agile/Scrum environment Collaborating with international and cross-functional teams Ideal candidate profile Minimum 5 years of experience in software testing Hands-on experience in manual testing of complex systems (embedded/system-level preferred) Strong experience in test design, execution, and documentation Experience in requirements analysis and test coverage planning Solid skills in defect identification and reporting Experience with tools such as JIRA, Confluence, MS Teams, Office 365 English level: minimum B2 Conditions Location: on-site (Wrocław) Contract type: B2B Salary: 90–110 PLN net/h Benefits: Private medical care, life insurance, Multisport card Recruitment steps Phone call with a Recruiter (approx. 30 min.) Interview with Client Decision and feedback

🏢 Summary: Lead Data Engineer serving as an SME to design, implement, and sustain secure, automated data pipelines supporting mission systems across a government software ecosystem. The role focuses on building scalable ETL workflows, defining data exchange interfaces, and ensuring interoperability and RMF compliance in highly regulated environments. You will enable reliable ingestion, transformation, and dissemination of mission-critical data across internal and external systems. 🗂️ Requirements: Bachelor’s degree with 9+ years of experience or Master’s with 7+ years or PhD/JD with 4+ years in relevant field, 7+ years experience in software engineering, systems integration, or platform implementation in DoD, IC, SAP/SCI, or similar environments, Experience designing or implementing data pipelines, ETL workflows, or data integration architectures, Experience with structured and semi-structured data formats, Active Top Secret clearance with ability to obtain SCI and Special Program access, Willingness to undergo polygraph examination 📃 Skills: Python, ETL, JSON, CSV, XML, Apache, NiFi, Airflow, Pandas, NumPy, REST, RMF, PPSM, Palantir, Foundry 🏢 Description: Job Description Seeking a Lead Data Engineer / Mission Data Pipeline to serve as a Subject Matter Expert (SME). You will work directly with government, technical, and industry stakeholders design, implement, and sustain data pipelines that ingest, transform, store, and distribute mission-relevant data across the DIFC2 software ecosystem and external mission partner systems/ You will support the development and delivery of software capabilities that improve data accessibility, mission integration, operational visibility, and cross-system interoperability across a highly dynamic mission environment. The focuses on enabling reliable, automated, and secure data flows that support mission capabilities on operational timelines. This position requires collaboration with mission system stakeholders, platform engineers, and security teams to define data exchange artifacts, develop pipeline implementations, and ensure interfaces comply with Risk Management Framework (RMF) requirements. The engineer will leverage both low-code/no-code ETL technologies and custom software development to implement scalable data pipelines that support the data architecture. Typical job responsibilities Include: Mission-Relevant Data Artifact Identification: Analyze mission workflows and system architecture to identify the data artifacts required to support operational capabilities. Define the structure, semantics, and lifecycle of mission data products within the data architecture. Ensure data artifacts align with architectural standards for interoperability, traceability, and reuse across mission components. Coordinate with External Stakeholders: Serve as the primary technical liaison for defining data exchange interfaces between mission systems. Collaborate with mission partners to define message schemas, data formats, transport mechanisms, and interface expectations. Document data interface specifications to support both system integration and operational sustainment. RMF & Security Documentation Support: Support the RMF process by defining technical details for machine-to-machine data interfaces. Produce or contribute to required RMF artifacts including: Data message descriptions Ports, Protocols, and Services Management (PPSM) entries System topology diagrams and interface documentation Coordinate with cybersecurity engineers to ensure pipeline implementations meet DoW security and compliance requirements. Data Pipeline Development & Sustainment: Design and implement automated data pipelines that ingest, transform, persist, and expose data artifacts for use by internal and external stakeholders. Utilize government-provided data platform infrastructure to build scalable ETL workflows. Develop custom transformation logic when required using appropriate programming languages and data processing frameworks. Expose processed data products through standardized service interfaces such as REST APIs or platform-native services. Data Pipeline Development & Sustainment: Implement data validation, normalization, and transformation logic to ensure accuracy and usability of integrated datasets. Troubleshoot data pipeline failures and implement monitoring, logging, and recovery mechanisms. Optimize pipeline performance to support mission timelines and large-scale data processing requirements. Deliverables & Key Projects Design and implementation of production data pipelines enabling automated ingestion and dissemination of mission data across systems. Technical documentation describing data artifacts, including purpose and operational relevance, source systems and ingestion methods, transformation logic, and destination systems and access interfaces Interface documentation supporting integration with external mission partners. RMF technical artifacts supporting security authorization of data interfaces. Continuous improvement and sustainment of the data pipeline ecosystem to support evolving mission needs. Qualifications 9 years of experience and a Bachelor's degree in Computer Science, Software Engineering, Management Information Systems/Information Systems, or a related discipline; or a Master's degree and 7 years of experience; or a PhD/JD and 4 years of experience. 7+ years of experience supporting software engineering, systems integration, platform implementation, or application development efforts within DoD, IC, SAP/SCI, or other complex mission environments. Experience designing or implementing data pipelines, ETL workflows, or data integration architectures. Experience working with structured and semi-structured data formats (JSON, CSV, XML, etc.). Requires an active Top Secret clearance with the ability to obtain and maintain Sensitive Compartmented Information and Special Program access, as well as a willingness to consent to a polygraph examination. You will wow us even more if you have experience will the following: Proficiency with low-code/no-code data orchestration technologies such as Apache NiFi, Apache Airflow, or similar ETL orchestration tools. Experience implementing data transformation logic using Python and data processing libraries such as Pandas and NumPy. Certification or demonstrated experience as a Palantir Foundry Data Engineer, including use of Code Repositories, Pipeline Builder, AIP Logic, and other platform-relevant technologies Experience designing pipelines that process and fuse large-scale datasets from multiple sources. Familiarity with DoW data architectures, mission system integration, or data interoperability frameworks. Ability to communicate effectively with engineers, architects, operators, and senior Government leadership while translating technical concepts into mission-relevant value. Proven ability to work in highly regulated, fast-moving environments where technical excellence, mission responsiveness, and stakeholder coordination are all critical to success. Blue Sky Innovators, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. If you are a qualified job seeker with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access http://www.blueskyinnovators.com as a result of your disability. To request an accommodation, please email us at careers@blueskyinnovators.com and provide your name and contact information. Please note: this is only for job seekers with disabilities requesting an accommodation.

🏢 Summary: The offer is for a Java Developer responsible for designing and developing backend solutions for genetic diagnostics and analytical software within an international Scrum team. The role involves system and API integration, database work, and maintaining software quality in a biotechnology environment. It is a hybrid B2B position based in Wrocław. 🗂️ Requirements: Minimum 4 years of experience as Java Developer, Experience with Java 17, Experience with Spring 6, Experience with Hibernate 6 or JPA, Experience with Angular, Experience with PostgreSQL, Experience with Gradle, Experience with Docker, Ability to work in Scrum/Agile environment, English level minimum B2 📃 Skills: Java, Spring, Hibernate, JPA, Angular, PostgreSQL, Gradle, Docker, Scrum, Agile 🏢 Description: For our client we are currently looking for a Java Developer who, together with the team, will be responsible for the technical aspects of the project related to genetic diagnostics. In this position you’ll collaborate with a team from Poland and German and be a part of global company in the field of biotechnology and molecular diagnostics. Key responsibilities Designing and developing backend solutions in Java Working in a Scrum/Agile team System and API integration Working with databases Developing diagnostic and analytical software Participating in testing and quality maintenance Working in an international environment Ideal candidate profile Minimum 4 years of experience in a similar position Experience with Java minimum 17 (required) Spring version 6 and Hibernate 6 / JPA (required) Experience with Swing Experience using Gradle Knowledge of Docker English language: minimum B2 Nice to have: experience with unit testing and AI tools Conditions Location: hybrid in Wrocław, Poland (Initially 2–3 days/week in the office, with the possibility to reduce to 1 day/week later) Contract type: B2B Salary: 130-150 PLN/h + VAT Benefits: Private medical care, life insurance, Multisport card Recruitment steps Phone call with a Recruiter (approx. 30 min.) Interview with Client (1,5h) Decision and feedback

🏢 Summary: The offer is for a Manual Tester responsible for ensuring quality across project deliveries by performing functional and exploratory testing, validating UI and backend solutions, and supporting release readiness. The role covers the full testing lifecycle, including test design, execution, defect investigation, and collaboration within Agile teams. The tester also contributes to risk identification and supports test automation processes from a governance perspective. 🗂️ Requirements: 2–4 years of experience in manual QA or software testing, Strong functional testing skills, Strong exploratory testing skills, Ability to write clear test cases, Ability to create clear and reproducible defect reports, Experience with Jira and Zephyr or similar tools, Basic to intermediate SQL knowledge, Understanding of SDLC, Understanding of Agile/Scrum, Ability to identify and communicate risks early 📃 Skills: QA, Testing, FunctionalTesting, ExploratoryTesting, SQL, Jira, Zephyr, SDLC, Agile, Scrum, Postman, API 🏢 Description: We are looking for a Tester to strengthen quality across DGITS delivery projects. This role focuses on testing business and product solutions delivered by one of our projects. The tester contributes across the lifecycle: from refinement and test design, through execution and defect investigation, to release readiness and quality risk visibility. Key Responsibilities: Test features, integrations, and end-to-end flows across DGITS projects Design and execute functional tests based on requirements, acceptance criteria, risks, and dependencies Perform exploratory testing to uncover gaps, edge cases, and integration risks Validate quality across UI and backend, using SQL where needed Investigate defects and create clear, reproducible defect reports Maintain test cases and traceability in Jira/Zephyr or similar tools Identify missing information, testability gaps, and quality risks early Support release readiness by highlighting risks, coverage gaps, and known issues Collaborate with developers, BAs, POs, and PMs to improve delivery quality Support test automation process from design and governance perspective Required skills and experience: 2–4 years of experience in manual QA / software testing Strong functional and exploratory testing skills Ability to write clear test cases and defect reports Practical experience with Jira and Zephyr or similar tools Basic to intermediate SQL for validation and investigation Understanding of SDLC and Agile/Scrum Ability to identify and communicate risks early Strong quality ownership and collaboration skills Nice to have: API testing experience, e.g. Postman Experience with integrations or data-driven workflows Experience contributing to release readiness or go/no-go decisions Practical use of AI tools to support QA work, with proper validation We offer you: Salary: 9 000 - 11 000 PLN net/B2B (depends on experience) Work-life balance: hybrid service delivery model (2 times per week in the office) Semi-annual evaluation meetings and a clearly defined career path A friendly Buddy to guide you through the onboarding and further training and career opportunities Training possibilities for personal development after completing the onboarding period Space to implement your own ideas Other amenities, such as: Fitness card (Benefit Multisport) Private health care (EnelMed) An open and casual company culture filled with internal events The opportunity to quickly develop professionally on projects in Europe and all over the world Great integration events :) Referral Program How our recruitment process looks like: Interview with our recruiter (around 30 minutes) - online Technical interview withTeam Lead (around 1 hour) - online Open Day - Meeting at our office (will last about 4 hours

🏢 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 offer is for an Automation Tester to work on a genetic diagnostics project, focusing on test automation and CI/CD integration within an international biotechnology environment. The role involves creating and maintaining automated tests, API testing, and analyzing defects in collaboration with distributed teams. 🗂️ Requirements: Minimum 4 years of experience in automation testing, Experience with Playwright and Python or TypeScript/Java, Experience with API testing, Experience with CI/CD tools, Experience with test management tools such as Jira, Xray, TestRail, Zephyr or Azure DevOps 📃 Skills: Playwright, Python, TypeScript, Java, API, CI/CD, Jira, Xray, TestRail, Zephyr, Azure, DevOps 🏢 Description: For our client we are currently looking for Automation Tester who, together with the team, will be responsible for the technical aspects of the project related to genetic diagnostics. In this position you’ll collaborate with a team from Poland and German and be a part of global company in the field of biotechnology and molecular diagnostics. Key responsibilities Creating test cases Test maintenance (fixing broken/flaky tests) CI/CD integration Bug analysis Working in an international environment Ideal candidate profile Minimum 4 years of experience in a similar position Playwright + Python (with openness to switching to TypeScript in the future) or Playwright + TypeScript/Java Experience with API testing Experience with CI/CD tools Jira, Xray / TestRail / Zephyr / Azure DevOps (or similar) English language: minimum B2 Nice to have: Knowledge of ISO IEC 62304 standards for software Experience in regulated projects (medical industry) Conditions Location: hybrid in Wrocław, Poland (At the beginning, 2–3 days in the office are preferred, then to be agreed (possibility of coming to the office a few times per month)) Contract type: B2B Salary: 130-150 PLN/h + VAT Benefits: Private medical care, life insurance, Multisport card Recruitment steps Phone call with a Recruiter (approx. 30 min.) Interview with Client (1,5h) Decision and feedback