Manager, Quality Management System (QMS) and Document Services

OrganOx
Madison, NJ
Job Description
OrganOx is seeking a Manager, Quality Management System and Document Services to oversee the architecture and ongoing improvement of their QMS, ensuring compliance with regulations and company standards. This leadership role is crucial for building a strong and effective team focused on customer first, passion, respect, and a commitment to transplantation. Responsibilities include developing best practices, training programs, and managing resource requirements to ensure compliance and operational excellence.

Requirements

  • Lead and develop a high-performing QMS team.
  • Drive organizational capability in document services.
  • Ensure regulatory and quality compliance (US 21 CFR 820, EU MDR 2017/745, SOR 98-282, TGA MDR 2002, ISO 13485).

Benefits

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Disability coverage
  • Flexible spending accounts
  • 401(k) retirement plan
  • Paid time off
  • Holidays
  • Additional leave benefits
  • Employee discounts
  • Onsite wellness facility
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