Supplier Quality Manager

LanceSoft Inc; Raritan (NJ); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading regulatory affairs company in Raritan, New Jersey, is looking for a Customer Quality Specialist. This role focuses on supporting Post Market Regulatory Affairs activities, including complaint handling and regulatory reporting. The ideal candidate should have a Bachelor’s degree and 2-4 years of relevant experience. Key responsibilities involve submitting regulatory reports accurately, collaborating with various stakeholders, and participating in complaint investigations. This position offers opportunities to engage in projects and achieve productivity and accuracy targets.

Qualifications

• 2-4 years of related work experience required.
• RAC or ASQ certifications are a plus.

Responsibilities

• On-time submission and accuracy of regulatory reports.
• Review Medical Device Reports and Vigilance Reports.
• Interface with service centers and Hospitals for complaints.
• Participate in various projects and events.

Skills

Regulatory reporting

Complaint handling

Investigation

Collaboration

Knowledge of global regulations

Education

Bachelor’s Degree

Job description

Overview

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.

Responsibilities

• Responsible and accountable for on-time submission and accuracy of regulatory reports
• Review and complete determination associated Medical Device Report and/or Vigilance Report
• Knowledge of and familiarity with global regulations for reporting
• Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
• Interact positively with 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 trained 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
• All other duties as assigned

Qualifications

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

Additional Information

All your information will be kept confidential according to EEO guidelines.