Design Quality Engineer - Sonoma - SciPro

    SciPro
    SciPro Sonoma

    12 hours ago

    $90,000 - $155,000 (USD) per year * Upper Management / Consulting
    Description

    Responsibilities:

    • Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
    • Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
    • Support sterilization and biocompatibility assessments.
    • Own and maintain design control documentation.
    • Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
    • Maintain accurate test, validation, and risk records and report progress to leadership.
    • Support regulatory submissions (e.g., 510(k), CE Mark).
    • Lead root cause investigations and corrective actions related to design issues.
    • Support complaint investigations, nonconformances, and CAPAs after product launch.
    • Conduct DHF audits to ensure phase completion requirements are met.
    • Review and approve engineering documents and test reports.
    • Identify opportunities to improve product quality, reduce cost, and increase efficiency.

    Requirements

    • Bachelor's degree in Engineering or related field.
    • 10+ years of quality engineering experience in medical devices, including new product launches.
    • Experience with sterilization and biocompatability
    • Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
    • Experience with verification & validation (V&V) and FMEAs.
    • Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
    • Detail-oriented with strong documentation skills.
    • Quality certifications (CQE, CSQE, Six Sigma) are a plus.
    * This salary range is an estimation made by beBee
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