QA Product Complaint Specialist

Medical Device Quality Complaint Specialist (Bridgewater, NJ HQ; hybrid—onsite 3 days/week; remote 2 days/week; minimal travel up to 10%)

Responsibilities:
- Receive initial patient calls for medical devices; follow up for additional information; coordinate product returns.
- Accurately enter commercial/clinical/compassionate use complaints into internal software/QMS.
- Review complaints for accuracy/completeness, regulatory compliance needs, replacement needs, and unreported adverse events.
- Serve as technical subject matter expert; troubleshoot complaints with patients/caregivers.
- Conduct complaint investigations to determine root cause, determine resolution, and respond to complainants.
- Ensure adverse events from complaint system or follow-up are reported within 24 hours.
- Provide product and complaint training to internal/external stakeholders.
- Partner cross-functionally to improve Quality Assurance effectiveness.
- Manage workload/call volume within pre-defined KPIs.
- Identify opportunities to improve product complaint/device support processes; support complaint trending investigations and associated CAPA.

Qualifications / Required skills:
- Associate degree in engineering, life science, or related discipline (preferred).
- 3+ years of relevant Quality Assurance experience.
- Experience with patient calls/complaints intake 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).
- Demonstrated collaboration, accountability, passion, respect, and integrity.

Compensation (listed): $81,000–$103,000 annually.

Application instructions (listed): Current Insmed employees—apply via Jobs Hub in Workday.