Medical Device Quality Complaint Specialist (Medtech)

TL;DR

Medical Device Quality Complaint Specialist (Medtech): Managing the medical device complaint process, including intake and patient follow-ups, with an accent on root cause analysis and regulatory compliance. Focus on troubleshooting complaints with patients, coordinating product returns, and ensuring rapid adverse event reporting.

Location: Hybrid (Must be based in Bridgewater, NJ), onsite 3 days a week

Salary: $81,000–$103,000 Annual

Company

A global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases.

What you will do

• Manage complaint intake and entry into the QMS for commercial, clinical, and compassionate use devices.
• Troubleshoot complaints with patients/caregivers and perform detailed root cause investigations.
• Ensure all adverse events are reported within the strict 24-hour regulatory timeline.
• Coordinate product returns and provide complaint training to internal and external stakeholders.
• Partner with cross-functional departments to improve Quality Assurance effectiveness.
• Identify and implement process improvements for product complaints and device support.

Requirements

• Associate degree in engineering, Life Science, or a related discipline.
• Minimum 3 years of relevant Quality Assurance experience.
• Experience with patient calls and complaints intake within a regulated industry.
• Strong knowledge of cGMP and Good Documentation Practices.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook).
• Must be located in or able to commute to the Bridgewater, NJ office for a hybrid schedule.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage, including mental health support and wellbeing reimbursement.
• Generous paid time off, fertility/family-forming benefits, and caregiver support.
• 401(k) plan with competitive company match and annual equity awards.
• Access to the Company Learning Institute with LinkedIn Learning and leadership programs.
• Employee resource groups and opportunities for volunteering and community giving.