• Quality Assurance Manager

    Astrix Technology (South Bend, IN)


    Quality Assurance Manager

     

    Manufacturing

    South Bend, IN, US

    + Added - 21/04/2025

     

    Apply for Job

     

    Great Quality Assurance Manager opportunity to join a company focused on developing, manufacturing, and distributing innovative diagnostic and laboratory testing solutions.

     

    + _South Bend, IN 46628_

    + The range is $80k - $100k

    Quality Assurance Manager

    **Location:** South Bend, Indiana

     

    We are seeking an experienced Quality Assurance (QA) Manager to lead and oversee quality operations at our South Bend site. This role is accountable for ensuring compliance with the Quality Management System (QMS) and driving continuous product and process improvement.

    Key Responsibilities

    + Lead the QA team and serve as the site’s Management Representative.

    + Ensure compliance with ISO 9001, ISO 13485, FDA, and other regulatory requirements.

    + Direct CAPA activities, risk management, and root cause analysis.

    + Oversee internal and external audits (TUV SUD, BSI, FDA, etc.) and coordinate audit responses.

    + Lead Management Reviews and ensure QMS effectiveness.

    + Maintain SOPs, internal audit schedules, and training programs.

    + Communicate with regulatory bodies and manage regulatory inspections.

    + Mentor QA staff and foster a culture of quality and continuous improvement.

    Requirements

    + Bachelor’s degree in a science or engineering field.

    + Minimum 2 years’ experience in QA management (5+ years preferred).

    + Prior leadership in audits and regulatory inspections.

    + Strong knowledge of ISO 9001, ISO 13485, and cGMP standards.

    + Supervisory experience and strong leadership skills.

    Preferred

    + Experience in manufacturing, fermentation, or bioprocesses.

     

    This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!

    INDBH

    \#LI-DNP:

    We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.