- Primarily responsible for the investigation of reported complaint and analysis returned complaint products both desk and laboratory based
- Perform decontamination of returned products.
- Dispose of bio-hazardous materials and maintain biohazard laboratory
- Perform timely complaint investigations and analysis of non-returned and returned complaint products.
- Perform failure analysis and Interact with other departments regarding same
- Document the results of investigations and submit for approval
- Interpret, record, and verify test data, comparing to known standards and criteria.
- Prioritization of investigation records to achieve key metrics.
- Prepare weekly, monthly and quarterly reports, as applicable.
- All other duties as assigned.
- Results focused, self-motivated professional
- Must have Hepatitis B vaccination
- Minimum qualification: Degree in related discipline or combination of equivalent education and experience.
- 5 years’ experience in a Complaint investigator role with both hands on product experience and technical writing skills.
- Expert in working in an FDA and ISO 13485 compliant environment.
- Builds strong relationships by fostering open communications, respect and trust.
- Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.
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