Supplier Quality Manager

LanceSoft; Raritan (NJ); On-site; USD 65,000 - 85,000; Full time

Job summary

A leading company in the regulatory affairs sector is seeking a Customer Quality Specialist. This role involves supporting post market regulatory activities, handling complaints, and ensuring regulatory compliance. Ideal candidates will have a Bachelor's degree and experience in a related field.

Qualifications

• 2-4 years of relevant work experience preferred.
• RAC or ASQ certifications a plus.

Responsibilities

• Responsible for regulatory report submissions and accuracy.
• Interface with service centers for complaint reporting.
• Collaborate on investigations and complaints handling.

Skills

Attention to detail

Communication

Regulatory knowledge

Education

Bachelor’s Degree

Job description

OVERALL RESPONSIBILITIES:
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:
• 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.