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.