Manufacturing Quality Engineer - Portsmouth - Alexander Technology Group

    Alexander Technology Group
    Alexander Technology Group Portsmouth

    16 hours ago

    $70,000 - $115,000 (USD) per year *
    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

    • 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.

    Qualifications

    Required

    • 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.

    Preferred

    • 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.
    * This salary range is an estimation made by beBee
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