Compliance Investigator

1 week ago


Austin, Texas, United States ICU Medical Full time
Job Title: Compliance Investigator

ICU Medical is seeking a highly skilled Compliance Investigator to join our team. As a Compliance Investigator, you will be responsible for investigating and resolving compliance issues related to our manufacturing processes.

Key Responsibilities:
  • Conduct thorough 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 they are completed within the required time schedule.
  • Provide support during regulatory or third-party audits.
  • Prepare departmental metrics and utilize trend data to develop schedules and incorporate into facility investigations.
  • Ensure accurate project schedules are maintained and communicated to management.
Requirements:
  • Bachelor's Degree in Engineering, Science, or Manufacturing (or equivalent experience).
  • Minimum of 2 years' experience in Quality, Manufacturing, Engineering, or R&D functions.
  • CQA or CQE certification preferred.
  • Experience in project management and quality engineering principles preferred.
What We Offer:

ICU Medical offers a competitive salary and benefits package, as well as opportunities for professional growth and development.



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