Design Quality Assurance Engineer

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; <10% travel 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.