Design Quality Assurance Engineer

Job Description Job Description Design Quality Assurance Engineer Ensures Design Control compliance across the full product development lifecycle (planning/inputs → development → V&V → design transfer/changes) for contract development/manufacturing programs serving medical device customers (with aerospace/defense exposure a plus). Acts as the embedded quality authority on project teams, trains and coach's engineers , maintains Design History Files (DHF) , and ensures products transfer into Manufacturing in a fully compliant, audit-ready state. Key responsibilities Own/oversee Design Controls & DHF : review/approve deliverables (inputs/outputs, design reviews, V&V, transfer, change orders), audit DHF completeness/traceability, escalate gaps/risks. Training & support : build and deliver Design Controls training; participate in design reviews, ensure actions tracked and documented. Risk, V&V, design transfer : facilitate risk management (e.g., FMEA/hazard analysis), ensure traceability and objective acceptance criteria, investigate test failures; lead quality aspects of transfer ensuring DMR/technical package and manufacturing readiness. Audits & CAPA : support internal/customer audits; investigate design-related nonconformances, perform root cause, drive CAPAs to closure. Qualifications/experience 5+ years of quality engineering with direct medical device design & development involvement (aerospace a plus). Strong knowledge of FDA 21 CFR 820 , ISO 13485 , ISO 14971 , AS9100 (design/development). Experience with DHF , V&V review/approval , and design transfer ; contract development/manufacturing experience preferred. MS Office 365; familiarity with eQMS/PLM/ERP preferred. BS in engineering/technical field (or equivalent); certifications like ASQ CQE/RAC preferred. Other notes Location: There are two locations in MA where this position can be based. Near Devens or 20minutes west of Fitchburg. Growth potential : Manager of Quality Compensation: TBD based on experience and fit Benefits: Full Reports to : Director of Quality & Regulatory Reason open : company growth and expansion No direct reports. Work in office/manufacturing/lab/cleanroom environments; possible. About my client: For over 40 years, my client has been a leader in the design and development of components and products for medical and aerospace applications.