February 19, 2020

MANAGER, QUALITY ASSURANCE AND REGULATORY AFFAIRS

This individual, reports directly to the COO or General Manager.

REQUIREMENTS for QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER 

  • Must demonstrate an understanding of quality policies, procedures and processes.
  • Requires knowledge of company’s requirements for and commitment to compliance with company policies and procedures and the standards of regulatory agencies, including ISO13485 and the Food and Drug Administration Quality System Regulations.
  • Requires bachelor’s degree in science from an accredited university or ten years’ experience in a quality-related field.

COMPENSATION for QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER 

  • $40-65k depending on experience
  • Competitive benefit package

DUTIES for QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER 

  • Supervises Quality Control and Audit staff.
  • Responsible for the Quality Management System (QMS), QMS policies and procedures and the Quality Manual, under direction from the COO and the General Manager.
  • Responsible for the internal and external audit programs.
  • Coordinates and evaluates the effectiveness of Corrective and Preventive Action.
  • Management representative for ISO13485 and FDA QSR.

HOURS for QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER 

  • Mon-Fri, 7:00am-3:30pm
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