What are the responsibilities and job description for the Quality Engineer position at Grove Technical Resources, INC?
Job Title: Quality Engineer II – Medical Device
Job Location: Billerica, Massachusetts (Fully onsite)
Type: W2 contract
Duration: 12 months
Note: Only Medical devices background experience is required.
Seeking a Quality Engineer with 2 years of medical device experience, strong NCMR & CAPA expertise, and solid understanding of FDA 21 CFR 820, ISO 13485, and EU MDR. Must be experienced in regulated manufacturing environments and comfortable collaborating with cross-functional teams.
Key Skills:
- Medical device quality (NCMR, CAPA, QMS)
- Process validation & documentation
- Root cause analysis & problem-solving
- Knowledge of FDA, ISO 13485, EU MDR
- Cleanroom / regulated manufacturing experience
Role Highlights:
- Lead and manage NCMRs & CAPAs
- Support manufacturing with NC assessments
- Perform quality line walks for compliance
- Drive process improvements and quality standards
- Partner with engineering, manufacturing, and QA teams