QA Product Complaint Specialist

Medical Device Quality Complaint Specialist

Reporting to the Director, Product Quality Complaints, the Medical Device Quality Complaint Specialist will play a key role in the medical device complaint process. Specific areas of responsibility include ensuring accurate and thorough complaint intake information, replacement need, troubleshooting with complainant, patient follow-ups, product complaint investigations, tracking and trending of complaint data. The position will be based in Bridgewater, NJ HQ (onsite 3 days a week).

In this role, you'll have the opportunity to receive initial patient calls on medical devices, provide follow-up for additional information and coordinate product returns. You will also:

• Accurately enter commercial, clinical and/or compassionate use complaints into the internal software system/QMS.
• Review each assigned complaint for accurate/missing information, complaint details, further regulatory compliance actions, replacement needs, or unreported adverse events.
• Act as a technical product subject matter expert and trouble shoot complaints with patients or caregivers.
• Perform complaint investigations to determine root cause, identify resolution and respond to the complainants.
• Ensure adverse events reported through the complaint system or at patient follow-up are reported within 24 hours.
• Provide product training and complaint training to internal and external stakeholders.
• Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
• Manage workload and call volume within pre-defined KPIs.
• Recognize and identify opportunities for improvement around product complaints and device support processes; shares best practices with the Patient Support & Quality teams.
• Support investigations associated to complaint trending along with associated CAPA.

You have a minimum of an Associate degree in Engineering, Life Science or related discipline preferred as well as a minimum of 3 years of relevant Quality Assurance experience.

You are or you have:

• Experience with the patient calls/complaints intake in a regulated industry, a must,
• Knowledgeable on relevant cGMP's and Good Documentation Practices
• Excellent communication skills (verbal and written).
• Demonstrated ability to manage projects and variable workloads.
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Successfully exhibited Insmed's five (5) values:
  Collaboration, Accountability, Passion, Respect, Integrity.
• Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace.

This is a hybrid role based out of our Bridgewater, NJ office. You'll have the option to work remotely 2 days out of the week, with in-person collaboration when it matters most.

Travel:

Minimal travel expected up to 10%.

Pay Range:

$81,.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to Linked In Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.