Senior Manufacturing Quality Engineer; Medical Device
Job in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listed on 2026-06-26
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-06-26
Job specializations:
-
Engineering
Quality Engineering, Medical Device Industry, Manufacturing Engineer -
Manufacturing / Production
Quality Engineering, Medical Device Industry, Production QC/QA, Manufacturing Engineer
Job Description & How to Apply Below
Seeking a hands-on Senior Quality Engineer to support manufacturing quality activities in a medical device production environment. This role focuses on production and process quality, working closely with Manufacturing, Validation, and Operations teams to ensure compliant and efficient manufacturing processes.
Key Responsibilities- Provide day-to-day quality engineering support for manufacturing operations
- Support production and process controls
- Lead and support Process Validation and TMV activities
- Develop and maintain PFMEAs, CAPAs, CPQs, and CTQs
- Author and update protocols, reports, and quality documentation
- Partner with Manufacturing Engineering, Validation, and Operations teams
- 5+ years of Quality Engineering experience in medical device manufacturing
- Strong experience in production/process quality
- Experience supporting electromechanical medical devices
- Hands-on experience with Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ management
- Strong technical writing and documentation skills in regulated environments
- Ability to work on the manufacturing floor and support daily quality activities
- Experience with Agile PLM
- Hands-on, execution-focused quality professional
- Strong independent documentation and problem-solving skills
- Comfortable working cross-functionally in a fast-paced manufacturing environment
Position Requirements
10+ Years
work experience
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