QA Product Complaint Specialist

About the Role

Reporting to the Director, Product Quality Complaints, the Medical Device Quality Complaint Specialist supports the medical device complaint process. Responsibilities include accurate complaint intake, replacement need assessment, troubleshooting with complainants, patient follow-ups, complaint investigations, and tracking/trending of complaint data. Based in Bridgewater, NJ HQ (onsite 3 days/week).

• Receive initial patient calls on medical devices; follow up for additional information and coordinate product returns.
• Enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS.
• Review assigned complaints for complete/accurate information, regulatory compliance actions, replacement needs, and unreported adverse events.
• Serve as a technical product subject matter expert and troubleshoot with patients/caregivers.
• Conduct complaint investigations (root cause, resolution) and respond to complainants.
• Ensure adverse events are reported within 24 hours.
• Provide product and complaint training to internal and external stakeholders.
• Partner cross-departmentally to improve Quality Assurance effectiveness.
• Manage workload/call volume within pre-defined KPIs.
• Identify improvement opportunities for complaint/device support processes; share best practices.
• Support complaint trending investigations and associated CAPA.

• Associate degree in Engineering, Life Science, or related discipline (preferred).
• 3+ years of relevant Quality Assurance experience.
• Required:
  
  Patient calls/complaints intake experience in a regulated industry.
• Knowledge of cGMPs and Good Documentation Practices.
• Excellent verbal and written communication.
• Ability to manage projects and variable workloads; highly organized with strong attention to detail.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Demonstrate collaboration, accountability, passion, respect, and integrity.

• Ability to interact successfully in a dynamic, culturally diverse workplace.

Minimal travel up to 10%.

$81,000.00– annual.