Quality Engineer

A growing medical device company based in the Los Angeles area is seeking a Quality Engineer to support quality engineering activities across the product lifecycle. The company develops next-generation biometric sensor devices for hospital use and cloud-based clinical software solutions. The Quality Engineer will be responsible for leading hardware-related complaint investigations, root cause analysis, and resolution.

This role holds ownership of the Risk Management File (RMF) and contributes strategic input to risk management across the Product Development Lifecycle (PDLC). The position supports design controls, design verification/validation, and ensures compliance with ISO 13485:2016, ISO 14971:2019, 21 CFR 820, and applicable EU/UK MDR requirements. This individual will work cross-functionally with design, quality, regulatory, and post-market teams to ensure product safety and performance. This role will require working onsite 4 days/week at the LA office.

Key Responsibilities:

• Lead hardware product complaint investigations and failure analysis to determine root cause and implement corrective actions.
• Own and maintain the Risk Management File (RMF) throughout the product lifecycle in accordance with ISO 14971 and EU MDR Annex I.
• Execute risk management activities across the PDLC, including hazard analysis, risk evaluation, and mitigation during design, manufacturing, and post-market phases.
• Perform and document product risk assessments (DFMEA, UFMEA, HHE/HHA) and support development of risk management plans and reports.
• Ensure design control compliance (ISO 13485) with risk mitigations traceable across requirements, verification, and validation.
• Collaborate cross-functionally with engineering, manufacturing, quality, regulatory, marketing, and post-market teams to support design transfer and lifecycle risk management.
• Contribute to Technical File and Design History File documentation supporting EU MDR/CE Mark and FDA submissions.
• Develop and execute verification & validation (V&V) test plans, applying statistical methods (DOE, regression, capability analysis) to support reliability and test method validation.
• Support compliance with medical electrical safety standards (IEC 60601, IEC 61000) and participate in CAPA investigations, audits, and regulatory inspections.

Required Skills & Experience:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, Quality) or related technical/scientific discipline.
• 3–5+ years of Quality Engineering experience in FDA-regulated, ISO 13485 medical device environments.
• Experience investigating hardware complaints, performing root cause analysis, and supporting CAPA activities.
• Ownership or maintenance of Risk Management Files and participation in risk management activities per ISO 14971.
• Hands-on experience with design verification & validation (V&V), including protocol development, execution, and traceability, and design transfer activities such as risk assessments and process capability review.
• Proficiency with statistical tools (Minitab, JMP) for DOE, capability analysis, and test method validation.
• Familiarity with FDA 21 CFR Part 820 and EU/UK MDR Technical File documentation, and experience with electronic QMS (e.g., Greenlight Guru, MasterControl).
• Experience supporting audits by FDA, Notified Bodies, or internal/external quality functions.
• Strong communication, documentation, and cross-functional collaboration skills, and willingness to travel domestically (<10%) to contract manufacturing sites.