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Manufacturing Quality Engineer
Job in
Portsmouth, Rockingham County, New Hampshire, 00215, USA
Listed on 2026-01-30
Listing for:
Alexander Technology Group
Full Time
position Listed on 2026-01-30
Job specializations:
-
Manufacturing / Production
Quality Engineering, Medical Device Industry -
Engineering
Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
Overview
Alexander Technology Group is looking for Manufacturing QA Engineer for a client in the Portsmouth area.
This is full-time and on-site.
No 3rd party c2c applicants will be considered, do not reach out
Key Responsibilities- Provide on-the-floor quality engineering support to manufacturing operations for combination products.
- Perform and document line clearances prior to batch start, product changeovers, and as required throughout production.
- Ensure labeling control requirements are met.
- Conduct incoming inspection of components and materials (visual, dimensional, and functional tests as applicable).
- Perform batch record reviews (BRR) for completeness, accuracy, and GMP compliance.
- Ensure that all work adheres to applicable cGMP, ISO, and FDA regulatory requirements for combination products.
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field — or equivalent practical experience.
- 3-5 years prior experience in a regulated manufacturing environment (pharma, medical device, or combination products preferred).
- Basic understanding of quality systems, cGMP, and data integrity principles.
- Experience with combination product manufacturing, device assembly lines and/or cleanroom experience.
- Knowledge of FDA 21 CFR Part 4, 210, 211 and 820, ISO 13485, or similar regulatory standards.
If interested, please send resume to josh at
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