Quality Assurance/Regulatory Affairs Manager

4 weeks ago


Chicago, Illinois, United States Richardson Electronics Full time
Job Title: Quality Assurance/Regulatory Affairs Manager

At Richardson Electronics, we are seeking a highly skilled Quality Assurance/Regulatory Affairs Manager to join our team. As a key member of our healthcare operations, you will be responsible for ensuring compliance with ISO 13485 and regulatory requirements.

Key Responsibilities:
  • Develop and manage the Quality Management System (QMS) for Healthcare CT tube manufacturing
  • Create, implement, and maintain policies and procedures to ensure full compliance with all regulatory requirements and policies, including ISO 13485 and 21 CFR Part 820.
  • Lead the healthcare team in defining, developing, and implementing quality best practices, while harmonizing with practices used across other global Richardson quality systems.
  • Develop and track key metrics for quality system and team performance, drive improvement, and communicate status.
  • Provide expertise and guidance in interpreting policies, regulatory, and/or governmental regulations, and agency guidelines to assure compliance.
  • Lead audit and inspection preparation, resolution of audit and inspection findings.
  • Ensure the quality assurance programs and policies are maintained and modified as needed.
  • Serve as the Healthcare Management Representative, ensuring Quality Management System processes are established, implemented, and maintained, and reporting to Management on QMS performance and areas for improvement.

Qualification Requirements:
  • Bachelor's degree required.
  • 7+ years of medical device quality or regulatory experience.
  • 5+ years of management experience.

About Richardson Electronics:
Richardson Electronics is a leading global manufacturer of engineered solutions, power grid and microwave tubes, and related consumables; power conversion and RF and microwave components, including green energy solutions; high-value replacement parts, tubes, and service training for diagnostic imaging equipment; and customized display solutions. We serve customers in the alternative energy, healthcare, aviation, broadcast, communications, industrial, marine, medical, military, scientific, and semiconductor markets.

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