• Quality Engineer I -Medical Devices

    Astrix Technology (Irvine, CA)


    Quality Engineer I -Medical Devices

     

    Manufacturing

    Irvine, CA, US

    Pay Rate Low: 32.60 | Pay Rate High: 43.50

     

    + Added - 10/09/2025

     

    Apply for Job

     

    Exciting 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 Engineer I

    **Location:** Irvine, CA

    **Industry:** Medical Devices

    **Pay:** 32.60-43.50 DOE

    **Contract:** 12 month contract with potential extension to 18 Months or conversion

    **Benefits:** Medical, Dental, Holiday, PTO 401K matching

    **Hours:** Mid Shift (Mon–Fri, 12 PM–9 PM) (Training on 1st shift)

     

    We're seeking a **Quality Engineer I** to ensure product excellence and regulatory compliance across manufacturing and post-market performance. You'll lead investigations, drive continuous improvement, and represent Quality in cross-functional teams—all while supporting the lifecycle of life-changing medical devices.

    Key Responsibilities:

    + Investigate and resolve product and process quality issues (customer complaints & nonconformities).

    + Lead root cause analysis, CAPA implementation, and effectiveness monitoring.

    + Analyze product performance using data-driven, risk-based methods.

    + Collaborate across teams to support quality initiatives and regulatory compliance.

    + Ensure adherence to FDA, ISO 13485, and company quality systems.

    + Troubleshoot returned devices and document technical findings.

    What You Bring:

    + Bachelor’s in Engineering.

    + 2+ years in a regulated industry (medical device/FDA preferred).

    + Solid understanding of FDA (21 CFR 820/803) and ISO 13485 standards.

    + Strong skills in problem-solving, risk analysis, and technical communication.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.