- Provide on-the-floor quality engineering support to manufacturing operations.
- Perform and document line clearances prior to batch starts, product changeovers, and throughout production.
- Ensure labeling controls and approved procedures are followed.
- Inspect incoming materials and components using visual, dimensional, and functional methods.
- Support in-process checks and execute final device testing; troubleshoot and escalate issues as needed.
- Review batch records for completeness, accuracy, and cGMP compliance, resolving discrepancies promptly.
- Initiate nonconformance reports, support investigations, quarantine affected materials, and assist with root cause analysis and CAPA implementation.
- Support equipment calibration activities and maintain accurate documentation.
- Ensure compliance with cGMP, ISO, and FDA requirements while contributing to continuous improvement efforts.
- Assist with audits, validations, change controls, and other cross-functional quality initiatives.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field (or equivalent experience).
- 3–5 years of experience in a regulated manufacturing environment (pharma, medical device, or combination products).
- Strong attention to detail with excellent organizational and documentation skills.
- Ability to work effectively on the production floor in a fast-paced setting.
- Working knowledge of quality systems, cGMP, and data integrity principles.
- Experience with combination products, device assembly lines, or cleanroom environments.
- Familiarity with root cause analysis tools (e.g., 5 Whys, Fishbone).
- Hands-on experience with inspection or measurement equipment.
- Knowledge of FDA regulations (21 CFR Parts 4, 210, 211, 820) and ISO 13485.
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Manufacturing Quality Engineer - Portsmouth - Alexander Technology Group
Description
Alexander Technology Group is partnering with a start-up combination Pharma/Med Device client looking to hire a Manufacturing Quality Engineer to join their team. This is a full-time, salaried position that will require being on-site in Portsmouth, NH daily.
Description:
The Manufacturing Line Quality Engineer provides hands-on quality support for production lines manufacturing combination products. This floor-facing role ensures materials, equipment, in-process activities, and finished products meet safety, quality, and regulatory standards. The ideal candidate is detail-oriented, proactive, and thrives in a fast-paced environment.
Key Responsibilities
Qualifications
Required
Preferred
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Quality Engineer
Only for registered members Portsmouth
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Manufacturing Quality Engineer
Only for registered members Portsmouth, NH
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Manufacturing Quality Engineer
Only for registered members Portsmouth
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Quality Engineering Architect
Only for registered members Portsmouth
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Manufacturing Quality Engineer
Only for registered members Portsmouth
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Quality Engineer
Only for registered members Newington
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Quality Engineer
Only for registered members Newington
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Quality Engineer
Only for registered members Newington
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Quality Engineer
Full time Only for registered members Newington
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Lead Solutions Engineer Quality Engineering
Only for registered members Portsmouth
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Quality Engineer – Aerospace Manufacturing
Only for registered members Portsmouth
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Manufacturing Line Quality Engineer
Only for registered members Portsmouth
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Sr Supplier Quality Engineer
Only for registered members Portsmouth
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Sr Supplier Quality Engineer
Only for registered members Portsmouth
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Quality Engineer II
Only for registered members Newington, NH
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Quality Engineer II
Only for registered members Newington
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Senior Software Quality Assurance Engineer
Only for registered members Portsmouth
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Quality Engineer
Only for registered members North Hampton, NH
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Quality Engineer Intern (4452)
Internship Only for registered members Newington
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CQV Engineer IV, Quality Control
Only for registered members Portsmouth, NH
