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Manufacturing Quality Engineer

Karwell Technologies

  • Northridge, CA
  • 22 days ago

    Highlights

    The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams. Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances.

    Numbers & Facts

    LocationNorthridge, CA

    Description

    Job Description:
    Responsible for ensuring product quality, regulatory compliance, and process adherence in manufacturing environments by monitoring production activities, managing quality systems, and driving resolution of non-conformances. The role involves CAPA management, root cause analysis, audit support, and implementation of continuous improvement initiatives while collaborating with cross-functional teams.
    Roles & Responsibilities:
    • Monitor manufacturing processes to ensure product quality and compliance with defined standards.
    • Manage non-conformances (Client), deviations, and CAPA activities.
    • Perform root cause analysis (RCA) and implement corrective and preventive actions.
    • Support internal and external audits (FDA, ISO).
    • Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP requirements.
    • Maintain and update Quality Management System (QMS) documentation including SOPs, DHF, DMR, and DHR.
    • Collaborate with manufacturing, engineering, and supplier teams to resolve quality issues.
    • Drive continuous improvement initiatives using Lean Six Sigma methodologies.
    • Perform process monitoring and support validation activities (IQ/OQ/PQ as required).
    • Ensure proper documentation and traceability of manufacturing and quality records.
    • Manufacturing Quality.
    • GMP.
    • ISO 13485.
    • FDA 21 CFR 820.
    • CAPA.
    • Client.
    • Root Cause Analysis (RCA).
    • Risk Management (FMEA).
    • Statistical Process Control (SPC).
    • Audit Compliance.
    • Quality Management System (QMS).
    • Continuous Improvement.
    Education & Experience :
    • Bachelor's degree in engineering or related field.
    • Experience in medical device manufacturing preferred.
    • Strong understanding of regulatory and quality systems.
    • Good communication and cross-functional collaboration skills.

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