Quality Engineer

We are looking for an experienced DHF Remediation Quality Engineer to support a leading Medical Device manufacturing team. This role focuses on Design History File remediation for on-market products and requires strong expertise in risk management and traceability.Key Responsibilities:Lead and support DHF remediation activities for on-market productsDevelop and maintain traceability matrices (user → design → manufacturing requirements)Author and support Risk Management documentation (Design FMEA, Application FMEA, Hazard Analysis)Ensure compliance with regulatory standards and quality systemsRequired Qualifications:Bachelor’s degree in Engineering, Science, or Mathematics5+ years in medical device industry (mid-to-large organizations)Minimum 2–3 years of DHF remediation experienceStrong understanding of traceability and risk management