Job Summary
We are seeking a detail-oriented and motivated Product Surveillance Associate III – Quality Investigator to join our team in Sturtevant, Wisconsin.
The selected candidate will be responsible for handling post-market product complaints, investigating reported product issues, providing technical support, and ensuring accurate documentation in compliance with applicable global regulatory requirements.
This role involves interacting with customers, healthcare professionals, and internal global teams to investigate product-related concerns, coordinate complaint resolution, and maintain high-quality customer service.
The ideal candidate should have strong communication, analytical, documentation, and problem-solving skills.
Key Responsibilities
- Receive and handle customer inquiries through phone calls, emails, and other communication channels.
- Evaluate reported product issues and determine whether they qualify as complaints.
- Document complaints accurately in accordance with applicable Standard Operating Procedures (SOPs).
- Provide technical support and remote troubleshooting guidance when required.
- Review relevant records and contact customers or product users to gather additional information regarding treatment, product performance, and functionality.
- Conduct regular follow-ups to ensure complaints are investigated and closed within established timelines.
- Manage customer relationships and expectations throughout the complaint investigation process.
- Conduct product complaint investigations, including coordinating product returns and subsequent product evaluations.
- Review manufacturing records and ensure all necessary approvals are obtained before complaint closure.
- Analyze reported issues and develop solutions to basic problems.
- Complete all assigned training within the required timelines.
Additional Responsibilities
- Support operational improvements to enhance complaint-handling efficiency.
- Participate in internal and external quality system audits.
- Evaluate product complaints and determine whether Medical Device Reporting (MDR) or other Vigilance Reporting is required.
- Perform additional job-related duties as assigned by the supervisor.
Required Skills & Qualifications
- Strong written and verbal communication skills.
- Excellent attention to detail and documentation accuracy.
- Strong analytical and problem-solving abilities.
- Ability to communicate professionally with customers, healthcare professionals, and internal teams.
- Ability to manage multiple investigations and follow-ups.
- Basic technical troubleshooting and assessment skills.
- Ability to understand and follow Standard Operating Procedures (SOPs).
- Strong organizational and time-management skills.
- Proficiency in basic computer operations and documentation.
Work Schedule
- Working Days: Monday – Friday
- Daily Hours: 8 working hours
- Lunch Break: 30 minutes unpaid
- Start Time: Between 7:00 AM and 9:00 AM CST
- Overtime: Potential overtime available