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Design Quality Assurance EngineerBiomedical Resource Consultants, Inc. • United States
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Design Quality Assurance Engineer

Biomedical Resource Consultants, Inc.
  • US
    United States
  • US
    United States
Jetzt Bewerben

Über

Job Description
Job Description
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;
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.
  • United States

Sprachkenntnisse

  • English
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