Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Responsibilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as follows:
1. Work as part of the complaint investigation team within QA.
2. Support complaint investigation and closure of customer complaints.
3. Track inter-company complaints from S&R and inter-company investigations.
4. Manage complaint returns and timely investigation and disposition.
5. Manage out of box failures of spare parts and coordinate with Service & Repair functions.
6. Report complaint data to management team.
7. Review and update policies and procedures as necessary.
8. Participate in CAPA teams and non-conformance investigations.
9. Assist in implementing process improvement initiatives throughout the facility.
10. Actively participate in product risk management activities.
11. Perform internal audits as per schedule.
12. Provide reports on quality performance and metrics as required.
13. Verify internal audit non-conformances.
Qualification:
While a 3rd level qualification in an Engineering or Scientific discipline is preferred, a minimum of 2 years’ experience working in a Quality function is acceptable, preferably in an FDA and/or ISO 13485 process environment.
The successful applicant must demonstrate:
* Strong interpersonal and communication skills.
* Excellent organization and administrative skills.
* Highly self-motivated team player, able to work under pressure.
* Ability to work with Engineering and Test Departments to support resolution of product failures.
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