Quality Investigator JR
13900 W. Grandview Parkway Sturtevant, WI 53177 US
Product Surveillance Activities
- Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s).
- Provide technical support and remote troubleshooting guidance as needed.
- Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.
- Conduct periodic follow-up to close complaints in a timely manner.
- Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure.
- Support statistical analysis of complaint trends.
Process Improvement Initiatives
- Recommend operational changes to improve efficiencies in all aspects of complaint handling.
Adherence to Regulations
- Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.
- Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.
- Associates Degree in nursing, pharmacy, medical technology, engineering or scientific background preferred
- Medical Device preferred
- Medical or surgical office experience preferred
- Customer service experience required
Requires Vision Assessment (20/20 near visual acuity & acceptable color vision)
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.