Quality Investigator JR
13900 W. Grandview Parkway Sturtevant, WI 53177 US
Job Description
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
Professional experience
- Medical Device preferred
- Medical or surgical office experience preferred
- Customer service experience required
Pay Rate Range: $20/hr. Salary will be commensurate with experience.
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