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Quality Complaints Manager

2 months ago

Irvine, California, United States Masimo Full time
Job Summary

The Manager, Quality Complaints MDR/MDV is responsible for overseeing the complaint handling process, with a focus on Medical Device Reports (MDR) and Medical Device Vigilance (MDV). This role involves managing the day-to-day complaint handling process, ensuring timely processing and reporting, and collaborating with internal teams to resolve complaints.

Key Responsibilities
  • Manage the complaint handling process, including investigation, review, and reporting of post-market adverse events.
  • Ensure compliance with FDA Quality System Regulations, EU Medical Devices Regulation, and related quality standards.
  • Collaborate with clinical teams to review complaints and assess patient risk and safety.
  • Provide training to internal team members on complaint handling processes and requirements.
  • Interface with hospital risk management personnel and physicians to conduct investigations.
  • Monitor trends in complaint handling and escalate issues to management as needed.
  • Serve as subject matter expert for MDR and MDV functions during internal and external audits.
Requirements
  • 8+ years of experience processing complaints in the medical device industry.
  • Experience with MedWatch and international adverse event reporting requirements.
  • Strong computer skills and organizational abilities.
  • Ability to interact effectively with internal and external customers.
  • Demonstrated attention to detail and ability to focus.
About Us

Masimo is a leading provider of noninvasive monitoring solutions. We are committed to improving patient outcomes and reducing the cost of care. Our Quality teams work closely with Regulatory Affairs and Engineering to ensure compliance with FDA standards and specifications.