• Quality Operations Specialist

    Astrix Technology (Irvine, CA)


    Quality Operations Specialist

     

    Engineering

    Irvine, CA, US

    Pay Rate Low: 32.00 | Pay Rate High: 36.00

     

    + Added - 25/08/2025

     

    Apply for Job

     

    Exciting Quality Specialist development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.

    Quality Operations Specialist

    1 year contract with extension or conversion potential

    **Location:** Irvine, CA

    **Pay:** 32 to 36 per hour

    About the Role:

    Join our team as a Quality Operations Specialist and play a key role in ensuring the safety and performance of our innovative medical devices. You'll lead hands-on investigations, analyze product performance, and support cross-functional improvements — all while helping us stay compliant with global regulatory standards.

    Key Responsibilities:

    + Investigate and document customer complaints and product issues

    + Perform hands-on troubleshooting of returned devices and nonconformities

    + Analyze trends in complaints, service calls, and manufacturing issues

    + Support complaint intake and coding verification

    + Collaborate with cross-functional teams to drive product and process improvements

    + Maintain compliance with FDA, ISO 13485, and global quality standards

    + Assist with manufacturing line support and quality documentation (e.g., SAP)

    Qualifications:

    Minimum:

    + Bachelor's in Mechanical or Electrical Engineering (Optical/Ophthalmic device experience preferred)

    + 0–2 years experience in a related role

    + Strong problem-solving and documentation skills

    + Proficient in Microsoft Excel

    Preferred:

    + Knowledge of FDA regulations (21 CFR 820/803), ISO 13485

    + Experience with medical device complaint handling and regulatory reporting (MDR, Vigilance, etc.)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.