Design Quality Assurance Engineer

Job Description Design Quality Assurance EngineerAre you the right candidate for this opportunity Make sure to read the full description below.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 responsibilitiesOwn/oversee Design Controls & DHFreview/approve deliverables (inputs/outputs, design reviews, V&V, transfer, change orders), audit DHF completeness/traceability, escalate gaps/risks.Training & supportbuild and deliver Design Controls training; participate in design reviews, ensure actions tracked and documented.Risk, V&V, design transferfacilitate 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 & CAPAsupport internal/customer audits; investigate design-related nonconformances, perform root cause, drive CAPAs to closure.Qualifications/experience5+ years of quality engineering with direct medical device design & development involvement (aerospace a plus).Strong knowledge of FDA 21 CFR 820ISO 13485ISO 14971AS9100 (design/development).Experience with DHFV&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 notesLocation: There are two locations in MA where this position can be based. Near Devens or 20minutes west of Fitchburg. xhyhwjd Growth potentialManager of QualityCompensation: TBD based on experience and fitBenefits: FullReports toDirector of Quality & RegulatoryReason opencompany growth and expansionNo direct reports.Work in office/manufacturing/lab/cleanroom environments;