Documentation Control Specialist

3 days ago


Grand Rapids, Michigan, United States SunMed Group Holdings, LLC dba AirLife Full time
Job Summary

We are seeking a skilled Document Control Specialist to join our team at SunMed Group Holdings, LLC dba AirLife. This role is responsible for ensuring the accuracy and integrity of our documentation, including Standard Operating Procedures (SOPs), Work Instructions, Protocols & Reports, and raw data archive and quality record retention programs.

The ideal candidate will have 2-3 years of experience in a medical device, drug, or related ISO regulated field and an Associates degree. A strong understanding of GMPs/QSR, ISO, and other regulatory guidelines is essential, as well as excellent attention to detail and computer skills.

This role offers a competitive salary of $65,000 - $75,000 per year, depending on experience, and opportunities for growth and professional development.

Responsibilities
  • Utilize ERP systems and maintain databases in support of operations, including auditing data, updating product statuses, and managing information obsoleting.
  • Work with Marketing Product Management teams to ensure part number and data base accuracy and current content.
  • Manage the final disposition process and process contributors of product inventory as products reach their end-of-life process and become discontinued.
  • Perform updates to documentation through an FDA and ISO13485 quality management system (QMS)
  • Identify and report item, inventory level, and order information to other departments


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