Quality Assurance Director

2 weeks ago

San Francisco, California, United States Safeguard Global Recruiting Full time
Job Title: Quality Assurance Manager

At Safeguard Global Recruiting, we are seeking a highly skilled Quality Assurance Manager to join our team. As a key member of our organization, you will be responsible for leading all quality-related activities, ensuring our medical devices meet stringent regulatory and industry benchmarks.

Key Responsibilities:

  • Develop and implement quality management systems to ensure compliance with ISO 13485 and FDA standards.
  • Lead internal and external audits to maintain certifications and meet regulatory demands.
  • Manage supplier quality, including conducting audits and tracking supplier performance.
  • Oversee non-conformance and Corrective and Preventive Actions (CAPA) programs.
  • Develop training initiatives to ensure all personnel are versed in GMP/GDP standards and company protocols.
  • Ensure batch record reviews are thorough and compliant.
  • Track key quality indicators (KPIs) to evaluate QMS effectiveness and identify areas for improvement.
  • Manage and resolve customer complaints, ensuring full regulatory compliance and thorough documentation.
  • Ensure all documentation is accurate and accessible, managing Engineering Change Orders (ECOs) and post-implementation tasks.

Requirements:

  • Bachelor's degree in a science or engineering discipline.
  • Minimum of 5 years in a quality management role, ideally within the medical device sector.
  • Strong working knowledge of ISO 13485 and FDA standards.
  • Demonstrated problem-solving and analytical capabilities.
  • Proven leadership and communication skills.
  • Familiarity with quality management systems/software.
  • Ability to work quickly and make informed decisions under pressure.
  • Certification in quality (e.g., CQE, CQA) is an advantage.

What We Offer:

  • Competitive pay with potential bonuses based on performance.
  • Health, dental, and vision benefits.
  • Employer-matched retirement savings plan.
  • Opportunities for skill development and career growth.
  • A collaborative and forward-thinking workplace.

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