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Manufacturing Jobs

Sr Quality Engineer

Karwell Technologies

  • Irvine, CA
  • 30+ days ago

    Highlights

    Requirements: Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience. Roles & Responsibilities: Perform Quality Engineering activities related to product development and ongoing cleanroom build support.

    Numbers & Facts

    LocationIrvine, CA

    Description

    Job Description:
    • The Sr Quality Engineer will support product development and cleanroom build activities within a medical device environment.
    • The role focuses on ensuring compliance with quality systems, regulatory standards, and supporting design assurance, risk management, and validation activities in collaboration with cross-functional teams.
    Roles & Responsibilities:
    • Perform Quality Engineering activities related to product development and ongoing cleanroom build support.
    • Ensure NPD processes comply with the quality system and applicable regulatory standards.
    • Update risk management and design control files and maintain relevant quality documentation.
    • Develop and execute test method validations and qualification plans.
    • Support design verification and facilitate process validation and commercialization activities related to multi-site transfer.
    • Work collaboratively with cross-functional teams, including R&D, manufacturing, regulatory, clinical, and marketing
    • Other duties assigned by Leadership.
    Requirements:
    • Bachelor's degree in Engineering or Scientific field & 4+ years' experience OR Master's degree or equivalent in Engineering or Scientific field & 3+ years' experience.
    • Strong preference for candidates with experience in NPD, Design Assurance (DA), and Quality Engineering.
    • Proficient understanding of medical device operations and/or manufacturing processes; medical device experience strongly preferred.
    • Relevant experience in product development, quality assurance, and/or related fields.
    • Knowledge and understanding of Engineering and Quality principles, theories, and concepts.
    • Understanding of ISO 13485.
    • Experience developing, updating, and maintaining technical content of risk management files.
    • Basic understanding of statistical techniques; experience using statistical software (e.g., Minitab) is a plus.
    • Experience in test method development including validation and/or fixture development.
    • Solid problem-solving, organizational, analytical, and critical thinking skills.
    • Good documentation and communication skills with attention to detail.
    • Ability to build productive working relationships and interact professionally with all organizational levels.
    • Ability to manage competing priorities in a fast-paced environment.

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