Complaint Analyst II

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

Qualifications:

• Bachelor's Degree or equivalent experience
• Generally requires 2-4 years of related work experience
• RAC or ASQ certifications a plus