Design Quality Assurance Engineer

B

Biomedical Resource Consultants, Inc.

Design Quality Assurance Engineer

National
Full Time
Paid
  • Responsibilities

    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.