Summary

The Sr. Complaint Handling Specialist will support the growth and continuous improvement of the Quality System, providing high level of hands-on support to ensure complaints are reviewed and assessed in a timely manner. Duties include, but are not limited to, day to day complaint review, complete investigation reports, adverse event reporting and maintain the complaints log and trends. 

Essential Duties

  • Evaluates complaints to determine complaint investigation, Medical Device and Vigilance Reporting in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, European Vigilance Reporting.
  • Support and participate in internal and external audits, risk management summaries and health hazard evaluations.
  • Ensure complaint documentation and records are complete and in compliance with regulatory requirements prior to closure.
  • Ensure timely completion of MDR and Vigilance reporting, as well as initial, supplemental and final incident reports to regulatory authorities within specified timelines.
  • Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.
  • Evaluate all information from a technical perspective to ensure appropriate analysis and investigation
  • Other duties as assigned

Education and/or Experience

  • Bachelors degree, plus a minimum of 5 years of related experience in the in-vitro diagnostics or medical device industry.
  • Minimum of 5 years in Complaint Handling processes.
  • Strong problem solving skills, critical-thinker, and experienced at investigating and resolving complex issues

Other Qualifications 

  • Etq Reliance QMS experiences is a plus
  • Excellent written and interpersonal communication skills.

Physical Demands

  • Comfortable performing repetitive tasks and/or motions.
  • Must be able to lift a minimum of 10 lbs.

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