Eko Health · 1 month ago
Product Quality Assurance Engineer (Medical Device)
Emeryville, CA
Full-time
Hybrid
Senior Level
5+ years expEko is a fast-growing digital health company dedicated to providing advanced tools for healthcare professionals. The Product Quality Assurance Engineer will ensure compliance with industry standards and regulations while supporting product development and quality management processes.
Artificial Intelligence (AI)Health CareHealth DiagnosticsMachine LearningMedical DevicemHealthSoftware
Responsibilities
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
Acts as the QA point of contact and Subject Matter Expert (SME) for activities related to validation and Quality Risk Management for assigned products/systems
Writes and/or reviews and approves validation documents. This includes, but may not be limited to, Validation Plans, Functional Risk Assessments, Application Design or Configuration Specifications, applicable Test Scripts or other documents as may be appropriate
Performs GxP-related activities in alignment with business requirements and ensures that 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 as applicable design inputs, product requirements specification, 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 report
Lead product specific quality system activities and processes per ISO 13485, including complaint handling and CAPA investigation, and 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
Qualification
Required
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 (such as 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
Preferred
Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or other relevant regulatory authority regulations and guidance related to CSV (such as, GMP, GAMP, Part 11, Annex 11, ICH Q9, etc.) activities and compliance
In-depth knowledge of relevant CFR (Title 21), Food and Drug Administration (FDA) and International Conference on Harmonization (ICH) guidelines including thorough knowledge of appropriate GCP, GLP, and GMP policies and procedures
Benefits
Paid-time off
Medical/Dental/Vision, Disability + Life Insurance
One Medical membership
Parental Leave
401k Matching
Work from home equipment stipend
Flexible schedules
Wellness programs (Wellness Wednesdays, Time off)
Wellness perks (Headspace, Ginger, Aaptiv, Physera)
Learning and Development stipend
Company
Eko Health
Eko Health is a digital health company providing digital stethoscopes and an AI detection platform for diagnosing heart and lung diseases.
51-200 employees
H1B Sponsorship
Eko Health has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (2)
Funding
Current Stage
Late StageTotal Funding
$173.2MKey Investors
National Institutes of HealthArtis VenturesDreamit Ventures
2024-06-05Series D· $41M
2022-09-20Grant· $2.7M
2022-03-22Series C· $30M
Leadership Team
Connor Landgraf
Co-founder & CEO
Tyler Crouch
Co-Founder & Lead Product Architect
Recent News
Research and Markets
2025-12-02
Company data provided by crunchbase