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