Medical Device Quality Complaint Specialist (Quality Assurance)

Location: Hybrid role based in the Bridgewater, New Jersey office; in-person work is required 3 days per week, with remote work available 2 days per week. Minimal travel expected, up to 10%.

Salary: $81,000–$103,000 annual.

Company

hirify.global is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.

What you will do

• Receive patient calls about medical devices, collect follow-up information, coordinate product returns, and assess replacement needs.
• Enter commercial, clinical, and compassionate-use complaints into the internal quality management system.
• Review complaints for completeness, regulatory compliance actions, replacement requirements, and unreported adverse events.
• Troubleshoot device complaints with patients and caregivers as a technical product subject matter expert.
• Investigate complaints, determine root causes, identify resolutions, and respond to complainants.
• Support complaint trending, CAPA investigations, product training, process improvements, and cross-functional quality initiatives.

Requirements

• Associate degree in Engineering, Life Science, or a related discipline preferred.
• At least 3 years of relevant Quality Assurance experience.
• Experience handling patient calls and complaint intake in a regulated industry is required.
• Knowledge of relevant cGMP requirements and Good Documentation Practices.
• Strong verbal and written communication, organization, attention to detail, and ability to manage variable workloads.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Culture & Benefits

• Purpose-driven environment focused on patients, scientific progress, collaboration, accountability, passion, respect, and integrity.
• Medical, dental, vision, and mental health support, wellbeing reimbursement, and an Employee Assistance Program.
• Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
• Learning programs, LinkedIn Learning, workshops, mentorship, employee resource groups, and service opportunities.