This position is responsible for evaluating, prioritizing, and investigating product complaints. Including but not limited to technical data analysis, monitoring, tracking and trending of product complaints. If assigned, act as a product line lead and subject matter expert. Including managing work load for the product line and identifying product issues and escalating them as appropriate. When required, ensure that feedback is provided to customers regarding the results of product complaint investigations.
1. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
2. Manage work load for assigned product line.
3. Analyze and investigate complex clinical and technical information to identify product issues and escalate them as appropriate.
4. Provide oversight of trending results reporting to business unit management.
5. Initiate CAPA determinations as appropriate.
6. Analyze adverse incident factors. May determine if events must be reported to Regulatory Authorities.
7. Provide complaint handling support and problem-resolution.
8. Ensure that product complaints are investigated per department procedures.
9. Perform due diligence information gathering.
10. Assign, delegate, and assist in the completion of complaint-related projects.
11. Ensure that communicated goals and objectives are achieved or exceeded.
12. Contribute to the development and implementation of procedures that ensure quality standards are met.
13. Execute projects that further the improvement and efficiency of the department.
14. As needed, collaborate with customer service, service, field service, technical support and clinical group on complaint investigations.
15. Attend meetings and prepare monthly reports as required.
16. Perform other duties as assigned. |
Requires a four-year college degree and a minimum of one year of experience in a regulated industry, preferably in a medical device complaint handling environment. Basic computer software skills, i.e. Microsoft Office. MS or MBA preferred. Certification(s) for particular engineering/quality discipline preferred. |
