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.
Job details are sourced from the employer's original posting.
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