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Engineering Jobs

Design Quality Engineer

Katalyst Healthcares & Life Sciences

  • Carlsbad, CA
  • 30+ days ago

    Highlights

    Job Summary: Quality Engineer with experience in the Medical Device industry, specializing in quality engineering, design assurance, risk management, design controls, and product verification & validation. Roles & Responsibilities: Support quality engineering and design assurance activities within the Medical Device industry.

    Numbers & Facts

    LocationCarlsbad, CA

    Description

    Job Summary:
    • Quality Engineer with experience in the Medical Device industry, specializing in quality engineering, design assurance, risk management, design controls, and product verification & validation. Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
    Roles & Responsibilities:
    • Support quality engineering and design assurance activities within the Medical Device industry.
    • Apply risk management principles, design controls, and product verification & validation processes.
    • Ensure compliance with global quality system regulations and standards, including ISO 13485 and ISO 14971.
    • Utilize advanced quality tools and statistical methodologies where applicable.
    Education & Experience:
    • Bachelor of Science degree in Engineering or a related technical field.
    • Minimum 3 years of experience in quality engineering or design assurance within the Medical Device industry.
    • Preferred degree in Biomedical Engineering or Mechanical Engineering.
    • Experience supporting structural heart, cardiovascular, or implantable medical devices preferred.
    • Certification in Quality Engineering (CQE) or related credential preferred.

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