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Quality Systems Director

1 week ago

Eden Prairie, Minnesota, United States Bracco Medical Technologies Full time

Bracco Medical Technologies creates innovative medical devices that help healthcare providers make informed decisions about patient care.

About the Role

This Senior Quality System Specialist position requires a highly skilled professional who can develop and maintain a robust quality system in compliance with all relevant standards and regulations.

Key Responsibilities:

  • Develop and implement quality system processes in support of corporate objectives
  • Lead the internal audit program and serve as a lead auditor for internal audits
  • Support external audits, internal audits, and supplier audits at domestic and international sites
  • Ensure compliance with FDA QSR/QMSR, ISO 13485, EU Medical Device Regulation (MDR), and other national and international regulations

Required Skills and Qualifications:

  • Bachelor's degree in a related field
  • 5+ years medical device experience including at least 3 years in Quality Management Systems
  • Strong knowledge and hands-on experience with FDA QSR/QMSR, ISO 13485, EU Medical Device Regulation (MDR), and other national and international regulations
  • Able to build relationships and work effectively with individuals at all levels of the organization
  • Ability to clearly and concisely articulate ideas both verbally and in writing