Associate, Product Quality Complaints

Insmed Incorporated

5d • $81,000 - $103,000 • Hybrid

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: Reporting to the Director, Product Quality Complaints, the Medical Device Quality Complaint Associate 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 our Bridgewater, NJ HQ (onsite 3 days a week).

Requirements

• Minimum Associate degree in engineering, Life Science or related discipline preferred, and a minimum of 3 years of relevant Quality Assurance experience.
• Experience with the patient calls/complaints intake in a regulated industry.
• 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.

Responsibilities

• Receive initial patient calls on medical devices, provide follow-up for additional information and coordinate product returns.
• 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.

Benefits

• 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 LinkedIn 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 501-1,000 employees