Complaint Analyst II

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
• Complaint determination
• Reportability assessments
• Conduct follow-ups with complainant, reporters
• Checking your own work
• Updating SharePoint
• 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

PROFESSIONAL EXPERIENCE REQUIREMENTS:

• Ability to work in a cross-functional matrix environment
• Active listening/ phone skills
• Collaboration and teaming skills
• Critical thinking skills
• Detail orientation
• Organization skills
• Prioritization and multi-tasking skills
• Strong verbal and written communication skills
• Knowledge of basic medical terminology
• Proficiency in MS Office (Word, Excel, Outlook, PowerPoint, Sharepoint)
• Continuous learner
• Global mindset
• Accountability for own work