Quality Manager

Design Hire
  • Racine, Wisconsin
    3 days ago

    Job Description


    Design Hire is seeking a Quality Manager to lead quality systems, inspection activity, and compliance efforts within a regulated manufacturing environment. This role is a strong fit for someone with hands-on quality leadership experience who can improve processes, support audits, and maintain high standards across production and documentation.

     

    Key Responsibilities

    • Manage quality management activities across inspection, documentation, corrective actions, and process controls.
    • Lead internal audit readiness and support external regulatory or customer audits.
    • Oversee quality inspection processes to ensure products meet specifications, standards, and release requirements.
    • Partner with operations, engineering, and production teams to resolve quality issues and improve manufacturing performance.
    • Maintain and improve procedures, records, training, and quality system documentation.

     

    Qualifications

    • 5+ years of quality experience in a manufacturing environment preferred.
    • Prior quality leadership or management experience required.
    • Medical device manufacturing experience strongly preferred.
    • Working knowledge of FDA audit requirements and regulated quality systems.
    • Experience with ISO 13485 preferred.
    • Background supporting fabrication processes, inspection methods, and production quality controls.
    • Strong understanding of corrective actions, root cause analysis, nonconformance handling, and documentation practices.
    • Strong communication, organization, accountability, and cross-functional leadership skills.

     

    Equal Employment Opportunity Statement

    Design Hire is proud to be an Equal Employment Opportunity / Affirmative Action employer. It is our policy to consider for employment all individuals regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, gender, sex, sexual orientation, gender identity and/or expression, genetic information, veteran status, or any other characteristic protected by federal, state or local law.

     

    Employment Eligibility: If hired, a Form I-9 Employment Eligibility Verification must be completed at the start of employment. Temporary work authorization or the need for sponsorship may disqualify you from employment.

     



    Numbers & Facts

    LocationRacine, Wisconsin
    Websitewww.designhire.com

    Skills

    • Communication Skillsunmatched
    • Corrective Actionunmatched
    • Cross-Functionalunmatched
    • Documentationunmatched
    • External Auditunmatched
    • FDA Requirementsunmatched
    • ISO (International Organization for Standardization)unmatched
    • Internal Auditunmatched
    • Leadershipunmatched
    • Manufacturingunmatched
    • Medical Equipmentunmatched
    • Performance Managementunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Process Control Engineeringunmatched
    • Process Improvementunmatched
    • Production Controlunmatched
    • Quality Controlunmatched
    • Quality Managementunmatched
    • Quality System Requirements (QSR)unmatched
    • Regulationsunmatched
    • Root Cause Analysisunmatched

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