Director of Quality Assurance

5 days ago


Pennsylvania, United States EPM Scientific Full time
Director of Quality Assurance

EPM Scientific is seeking a highly accomplished Director of Quality Assurance to join our team in Pennsylvania. As a key member of our organization, you will be responsible for the development, implementation, and improvement of our Quality Assurance and regulatory affairs functions.

This is a critical role that requires a strong understanding of regulatory requirements and a proven track record of success in a medical device environment. You will be the chief regulatory contact with all national and international regulatory authorities and will be responsible for ensuring compliance with all relevant regulations.

Key Responsibilities:
  • Develop and implement quality management systems to ensure compliance with regulatory requirements
  • Lead and direct quality continuous improvement activities, including remediation efforts to bring facilities, systems, and processes up to current CRL standards
  • Provide quality oversight to all production, validation, supply chain, and training functions
  • Collaborate with cross-functional teams to ensure effective implementation of quality management systems
  • Develop and maintain relationships with regulatory authorities to ensure compliance and resolve any issues that may arise
Requirements:
  • Minimum 10 years of experience in a medical device environment or related industry
  • Advanced degree in life sciences or related field preferred
  • Proven track record of success in a quality assurance or regulatory affairs role
  • Strong understanding of regulatory requirements and compliance
  • Excellent communication and leadership skills


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