Design Quality Assurance Engineer

Biomedical Resource Consultants, Inc.Devens, MA

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Overview

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On-site

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.
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.

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FAQs About Design Quality Assurance Engineer Jobs at Biomedical Resource Consultants, Inc.

What is the work location for this position at Biomedical Resource Consultants, Inc.?

This job at Biomedical Resource Consultants, Inc. is located in Devens, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.

What pay range can candidates expect for this role at Biomedical Resource Consultants, Inc.?

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