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Design Quality Assurance Engineer

Biomedical Resource Consultants, Inc.

Devens, MA

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JOB DETAILS
SKILLS
AS 9100, Aerospace and Defense, American Society for Quality (ASQ), Certified Quality Engineer (CQE), Change Requests/Orders, Cleanroom, Coaching, Code of Federal Regulations, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, ERP (Enterprise Resource Planning), Embedded Systems, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), File Maintenance, Hazard Analysis, Healthcare Software, ISO (International Organization for Standardization), Internal Audit, Maintain Compliance, Manufacturing, Medical Equipment, Microsoft Office, Product Development, Product Lifecycle, Product Lifecycle Management, Quality Assurance, Quality Engineering, Quality Management, Regulations, Risk, Risk Management, Traceability, Training/Teaching, Willing to Travel
LOCATION
Devens, MA
POSTED
30+ days ago

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.

    About the Company

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    Biomedical Resource Consultants, Inc.