Customer Quality member 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:
- Directly interface with Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events.
- Interact positively with customers, patients, internal/external business partners and colleagues
- Adhere and comply to work instructions, standard operating procedures, and regulations
- Expedite investigations by collaborating with internal/external business partners
- Achieve productivity targets
- Fully training within three months of hire
- Achieve accuracy targets for complaint documentations
- Participate in projects and events
- Report ability assessments
- Conduct follow-ups with complainant, reporters
- Tracking complaints in the process for closure
- Participate in CAPA activities and act as CAPA task owner as required
- Updating and revising work instructions
- Prepare responses to customers
- All other duties as assigned