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Quality Engineer

Katalyst Healthcares & Life Sciences

  • Lake Forest, CA
  • 2 days ago

    Highlights

    The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support. Job Summary: We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.

    Numbers & Facts

    LocationLake Forest, CA

    Description

    Job Summary:
    • We are seeking a Quality Engineer with experience in the Medical Device industry to support innovative healthcare products while collaborating with R&D, Regulatory, and cross-functional engineering teams.
    • The ideal candidate will have strong knowledge of Medical Device Quality Engineering, ISO 13485, ISO 14971, Design Controls, Risk Management, Verification & Validation (V&V), Change Control, CAPA, GxP Compliance, and Product Development Support.
    Roles & Responsibilities:
    • Support Medical Device Quality Engineering activities.
    • Collaborate with R&D, Regulatory, and cross-functional engineering teams.
    • Support Design Controls and Risk Management activities.
    • Participate in Verification & Validation (V&V) activities.
    • Support Change Control and CAPA processes.
    • Ensure compliance with GxP requirements.
    • Provide Product Development support.
    Education & Experience:
    • Bachelor's degree in Engineering or a related field.
    • 2+ years of Medical Device Quality Engineering experience.
    • Strong knowledge of Design Controls, Risk Management, and Regulatory Compliance.
    • Excellent communication and problem-solving skills.

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