Supplier Quality Manager

Overall Responsibilities:
The Customer Quality Specialist is responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting, and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development, and other functional experts.

Duties:

• Responsible and accountable for on-time submission and accuracy of regulatory reports
• Review and complete determination associated Medical Device Report and/or Vigilance Report
• Knowledge of and familiarity with global regulations for reporting
• Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
• Interact positively with internal, external business partners, and colleagues
• Adhere and comply with work instructions, standard operating procedures, and regulations
• Expedite investigations by collaborating with internal/external business partners
• Achieve productivity targets
• Fully trained within three months of hire
• Achieve accuracy targets for complaint documentations
• Participate in projects and events
• Complaint determination
• Reportability assessments
• Conduct follow-ups with complainant, reporters
• Checking your own work
• Updating Share Point
• Tracking complaints in the process for closure
• All other duties as assigned

Bachelor’s Degree or equivalent experience

Generally requires 2-4 years of related work experience

RAC or ASQ certifications a plus

All your information will be kept confidential according to EEO guidelines.