Senior Design Quality Engineer

Role: Senior Design Quality Engineer supporting design controls, risk management, and documentation for biopharma or medical device development, ensuring compliance throughout product lifecycle. Responsibilities: create and update Design and Development Plans, maintain risk management files (including hazard analysis, dFMEA, uFMEA), review and approve DHF deliverables, manage deviations, support design reviews, design transfer, change controls, post-market activities, and participate in process improvements and regulatory risk assessments. Requirements: Bachelor’s in engineering/science, 4+ years experience, strong knowledge of design controls, risk management, and regulations (ISO 13485, CFR Part 820, ISO 14971); proven ability to prepare technical documentation. Preferred: familiarity with ISO 15189, CAP/CLIA, GCP/GCLP, experience with eQMS and regulatory inspections. HighValue: focus on medical device regulation, design controls, risk management, validation, post-market activities, and cross-functional collaboration with assay development, lab operations, regulatory affairs, and quality teams. Work setup: likely on-site with up to 10% travel; requires flexibility for after-hours and emergency response.