Product Quality Assurance Engineer (Medical Device)

2 days ago Be among the first 25 applicants At Eko, we’re dedicated to providing healthcare professionals with industry‑leading digital tools to hear and understand their patients’ hearts and lungs. With our platform, clinicians can detect cardiopulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible. With over $165M in funding from partners like 3M and the Mayo Clinic, Eko has become one of the fastest‑growing digital health companies, doubling our customer base in the last year to over 500,000 clinicians across 4,000 U.S. hospitals. We’ve built a tremendously talented, diverse, and mission‑driven team and are proud to be certified as a Great Place to Work®. Together we are committed to investing in each other and our mission to ensure all patients have access to high‑quality care. The Product Quality Assurance Engineer will lead efforts to ensure Eko’s products are designed and developed in compliance with procedures and industry standards, regulations, and best practices. In this role the Product Quality Assurance Engineer will be responsible for following and maintaining our Quality Management System processes to support the development of products in compliance with international and U.S. medical device regulations. This role offers a high degree of autonomy and will work closely with the product development team to drive the completion of key design control, risk management, and change control deliverables for new product development and current on‑market products. The role will partner with cross‑functional groups to ensure audit-readiness across the quality management system, including complaints/feedback, CAPA/NC closures, internal audit planning/execution, and supplier evaluation/approval. The ideal candidate has worked in a medical device industry regulated by ISO 13485 and 21 CFR 820 and includes products containing both hardware and software aspects. This is a hybrid role with required onsite presence on Tue/Wed/Thu. As Product Quality Assurance Engineer at Eko, You Will: Support the new product development and sustaining engineering functions to ensure products are designed, developed and maintained, ensuring compliance with industry regulations and internal standards. Act as the QA point of contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned products/systems. Write and/or review and approve validation documents, including Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, and applicable Test Scripts. Perform GxP-related activities in alignment with business requirements and ensure they meet compliance standards as defined by the applicable regulations. Maintain an up‑to‑date knowledge of industry standards, regulations, and best practices related to quality management, and implement changes as necessary. Facilitate development and maintenance of product design documents, including design inputs, product requirements specifications, design output documents, DMR, DHF, and design traceability matrices. Support risk management activities to maintain a comprehensive product risk management file, including product hazard analysis/FMEA, use error analysis, and risk management reports. Lead product‑specific quality system activities and processes per ISO 13485, including complaint handling and CAPA investigation, supplier evaluations, training development and management, etc., to ensure product quality and proper implementation of compliant processes. Collaborate with internal teams to identify and implement improvements to quality management processes and ensure internal SOPs are compliant with applicable international and local regulations. As Product Quality Assurance Engineer at Eko, You Have: Bachelor’s degree in engineering, quality, life sciences, or a related field (or equivalent experience). 5+ years of experience in a Quality Assurance/systems role within a regulated industry. In‑depth knowledge of quality systems, ISO standards (e.g., ISO 13485), FDA regulations, ICH Quality, CRFs, and other relevant quality frameworks. Demonstrated experience leading or supporting the implementation of one or more state‑of‑the‑art medical device standards—such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 81001‑5‑1, or ISO 14155—with strong working knowledge of regulatory frameworks including 21 CFR 820 and EU MDR. As Product Quality Assurance Engineer at Eko, Good to Have Demonstrated, hands‑on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (e.g., GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance. In‑depth knowledge of relevant CFR (Title 21), FDA, and ICH guidelines, including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures. Benefits and Perks We Offer Eko was recognized by “Great Place to Work” in 2020 and 2021. Paid‑time off. Medical/Dental/Vision, disability and life insurance. One Medical membership. Parental leave. 401(k) matching. Work‑from‑home equipment stipend. Flexible schedules. Wellness programs (Wellness Wednesdays, time off). Wellness perks (Headspace, Ginger, Aaptiv, Physera). Learning and development stipend. Eko is elevating the way clinicians detect and monitor cardiac and respiratory disease by bringing together advanced sensors, patient and provider software, and AI‑powered analysis. Its FDA‑cleared platform is used by tens of thousands of clinicians treating millions of patients around the world, in‑person and through telehealth. The company is headquartered in Emeryville, California and privately‑held, with investments from ARTIS Ventures, NTT Venture Capital, DigiTx Ventures, Mayo Clinic, Sutter Health and others. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. Referrals increase your chances of interviewing at Eko Health by 2x. 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