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San Francisco Bay Area, CA

  • Quality Assurance and Regulatory Affairs Manager

    SUMMARY:

    Establish and maintain quality assurance system that adheres to QSR and ISO regulation. Manages quality
    and regulatory requirements for submission. Ensure all applicable Quality and Regulatory requirements are
    met and compliance with U.S. and international regulatory requirements.

    PRINCIPAL DUTIES AND RESPONSIBILITIES:

    • Manage Quality Assurance, Document Control and quality control activities.
    •  Create and maintain SOPs. Ensure that all employees follow written SOPs and process
      specifications.
    • Proactively champion quality assurance issues where applicable in company-wide activities.
    • Work closely with all departments to ensure new product development and transfers are in
      accordance to regulations.
    • Ensure that regulations are communicated through company policies and procedures.
    • Organize, assets on prepare and review FDA applications and other regulatory documents,
      including 510(k)s, Pre-market Approval Applications, Investigational Device Exemptions, and
      Medical Device Reports as needed.
    • Manage risk analysis documents and implement root cause analysis and implementation of
      corrective action for process related concerns.
    • Ensures that Quality Assurance/Quality Control operations are compliant, effective and efficient.
    • Maintain database for DMR, DHF, complaints ,NCMR, RMA, Deviations, IQC and CAPA
    • Participate in preparation of regulatory submission
    • Manage complaints to ensure timely and accurate receipt, logging, analysis and response to
      customer complaints and vigilance.
    •  Ensure timely resolution of supplier failure, corrective actions and prevention actions and all
      investigations.
    • Maintain current knowledge of federal and state regulations regarding QSR, ISO, and quality
      assurance issues.
    • Conduct Trend analysis for all critical process and monitor the trend. Present all quality control
      trends to the Executive Staff during management review.

    QUALIFICATIONS (EDUCATION, EXPERIENCE, SKILLS):

    • Required BS in life sciences, engineering, or equivalent. Master’s preferred.
    • Minimum six years related experience in the medical device industry.
    • Minimum three years of supervisory experience.
    •  Excellent communications and time management skills required. ASQC membership


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