Product Complaint Associate

Job description

MAIN JOB RESPONSIBILITIES / COMPETENCIES: 1. Act as consolidation point for receiving, processing, investigating and reporting product complaints. 2. Coordinate and/or perform the evaluation, investigation, follow-up and documentation of all STAAR product complaints. Maintain complaint files. 3. Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to: a. Interface with physicians and/or health care professionals regarding information relevant to the product complaint. b. Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements. 4. Perform prompt handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse event according to procedures. 5. Inform management responsible for complaint handling when information in a complaint suggests that action may be required to prevent unreasonable risk of substantial harm to the public, that there is an indication of a trend or that there are unusual adverse events. 6. Ensure incident reports (e.g. Medical Device...