Maintenance Documentation Coordinator

1 week ago


Austin, Texas, United States ICU Medical Inc. Full time
Job Description

As a Maintenance Documentation Coordinator at ICU Medical Inc., you will play a crucial role in maintaining accurate and up-to-date records of plant equipment preventive maintenance programs, equipment history files, and other critical plant files. You will also be responsible for adhering to cGMP guidelines and recommending updates to SOP's and plant policies/rules to maintain compliance where appropriate.

Key Responsibilities
  1. Maintain accurate and up-to-date records of plant equipment preventive maintenance programs, equipment history files, and other critical plant files.
  2. Ensure compliance of PM information and other data to FDA regulations and cGMP's/cGDP's by checking all incoming documentation.
  3. Assign equipment numbers to all new or modified equipment.
  4. Direct the issuance of PM work orders and ensure their timely completion by monitoring work and issuing periodic overdue reports.
  5. Maintain an intimate knowledge of all PM, DM, CM, filter, equipment number systems, such that retrieval for regulatory audits is done in a timely and efficient manner.

Requirements
  • High school diploma or equivalent; AA in electronics/mechanical preferred.
  • Minimum three years' experience with maintenance documentation experience.
  • Excellent organizational and time management skills.
  • Advanced skills in Excel.
  • Ability to pass GMP and area certifications and trainings.

Estimated Salary: $70,000 - $85,000 per year based on experience and qualifications.

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