Compliance Investigator

16 hours ago


Salt Lake, Utah, United States ICU Medical Full time
Job Summary

The Compliance Investigator will investigate and document exceptions to procedures, coordinate quality system programs and projects, and ensure regulatory compliance. This role requires strong technical writing skills, problem-solving abilities, and effective communication with all levels of management.

Key Responsibilities
  • Conduct investigations into process excursions, procedural exceptions, and nonconforming events.
  • Ensure root cause, corrective action, and preventive action are thoroughly addressed in investigations.
  • Document investigation results and develop, implement, and manage corrective action plans.
  • Provide training and conduct verification assessments to ensure adequate maintenance of quality systems and processes.
  • Manage projects to ensure timely completion and maintain accurate project schedules.
  • Support regulatory or third-party audits and prepare departmental metrics.
  • Utilize trend data to develop schedules and incorporate into facility investigations.
Requirements
  • Bachelor's Degree in Engineering, Science, or Manufacturing (or equivalent experience).
  • Minimum 2 years' experience in Quality, Manufacturing, Engineering, or R&D functions.
  • CQA or CQE certification preferred.
  • Experience in project management, quality engineering, and regulatory compliance.
Working Conditions

This role requires general office conditions with occasional entry to laboratories, warehouse, manufacturing, and clean-room manufacturing spaces. Occasional lifting of sample boxes is required, and the ability to lift up to 25 lbs. unassisted is necessary.



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