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Director, Quality

Director, Quality

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Director, Quality

Responsibilities

  • Establish and implement the companies Quality Management System (QMS)
  • Oversee all quality-related activities at the company
  • Ensure continuous improvement of the QMS along with GMP and GLP compliance
  • Ensure products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, customer requirements, and product specifications.
  • Prepare, oversee, and conduct internal and external audit programs.
  • Direct CAPA initiatives and measure effectiveness of corrective actions
  • Advise and train companies personnel on the preparation of documents regarding to QMS implementation
  • Review and approve changes to controlled documents and processes such as SOPs, specifications, etc.
  • Build Quality function across programs and mentor direct reports

Qualifications

  • Bachelor's degree in Engineering or related field.
  • Minimum 8 years of experience in a Quality function in a Medical Device company.
  • Leadership experience in a Quality function
  • Experience implementing quality process improvement initiatives.
  • Experience with document control, document review and auditing.
  • Knowledge and experience with standards (ISO 13485, IEC 60601, 21 CFR 820, 21 CFR 11)