QA Product Complaint Specialist

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 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 our Bridgewater, NJ HQ (onsite 3 days a week).

What You'll Do:

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.

• 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.

Who You Are:

You have a minimum of an Associate degree in engineering, Life Science or related discipline preferred, and 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.

• 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.

Where You’ll Work  

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 Requirements 

Minimal travel expected up to 10%.

#LI-EG1

#hybrid

Pay Range:

$81,000.00-103,000.00 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 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

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

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application   or interview process, please contact us by email at TotalRewards@insmed.com  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

 

• A reasonable accommodation, if one is available under applicable law, by emailing TotalRewards@insmed.com; and/or

• An alternative selection process by emailing Privacy@insmed.com.

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at Privacy@insmed.com.