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

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DePuy Synthes job descriptions may be revised at management's discretion, at any time.

• 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

 Problem solving/Root cause analysis skills

EDUCATIONAL REQUIREMENTS:

 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.