Medical Device Quality Complaint Specialist

TL;DR

Medical Device Quality Complaint Specialist: Managing the end-to-end medical device complaint process, including intake, investigation, and regulatory reporting with an accent on compliance and patient safety. Focus on troubleshooting technical product issues, performing root cause analysis, and ensuring adherence to cGMP standards within a hybrid work environment.

Location: Must be based in or able to commute to Bridgewater, NJ (Hybrid: 3 days onsite per week)

Salary: $81,000–$103,000 Annual

Company

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

What you will do

• Manage the intake of medical device complaints, ensuring accurate documentation in the QMS.
• Perform thorough complaint investigations to identify root causes and implement resolutions.
• Provide technical product support and troubleshooting for patients and caregivers.
• Ensure all adverse events are reported within the mandatory 24-hour window.
• Collaborate with cross-functional teams to improve device support processes and quality assurance effectiveness.
• Support complaint trending analysis and associated CAPA activities.

Requirements

• Minimum 3 years of relevant Quality Assurance experience in a regulated industry.
• Associate degree in Engineering, Life Science, or related discipline.
• Strong knowledge of cGMP and Good Documentation Practices.
• Proficiency in Microsoft Office suite.
• Excellent verbal and written communication skills.
• Must be able to work onsite in Bridgewater, NJ 3 days per week.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with mental health support.
• 401(k) plan with company match and annual equity awards.
• Generous paid time off and family-forming benefits.
• Access to the Company Learning Institute, including LinkedIn Learning and leadership programs.
• Supportive culture focused on collaboration, accountability, and patient impact.