Supplier Quality Manager

LanceSoft; Raritan (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Join a forward-thinking organization as a Customer Quality Specialist, where you'll play a crucial role in supporting Post Market Regulatory Affairs activities. This exciting position involves managing complaint handling, regulatory reporting, and collaborating with various teams to ensure compliance with global regulations. You'll be responsible for the accuracy of reports, conducting investigations, and interfacing with service centers and medical professionals. With a focus on quality and teamwork, this role offers the opportunity to make a significant impact in the medical device industry while achieving personal and professional growth.

Qualifications

• Bachelor’s degree or equivalent experience required.
• 2-4 years of related work experience preferred.
• RAC or ASQ certifications are a plus.

Responsibilities

• Responsible for accurate and timely submission of regulatory reports.
• Collaborate with internal and external partners for complaint investigations.
• Track and document complaints for closure.

Skills

Complaint Handling

Regulatory Reporting

Technical Evaluations

Collaboration

Medical Device Regulations

Education

Bachelor’s Degree

Equivalent Experience

Tools

SharePoint

Job description

OVERALL RESPONSIBILITIES:
The Customer Quality member is 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 oversees and directly supports 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:

1. Responsible and accountable for on-time submission and accuracy of regulatory reports
2. Review and complete determination associated with Medical Device Report and/or Vigilance Report
3. Knowledge of and familiarity with global regulations for reporting
4. Directly interface with service centers, hospitals, surgeons, and internal employees for reporting of complaints and adverse events
5. Interact positively with internal and external business partners and colleagues
6. Adhere and comply with work instructions, standard operating procedures, and regulations
7. Expedite investigations by collaborating with internal/external business partners
8. Achieve productivity targets
9. Fully trained within three months of hire
10. Achieve accuracy targets for complaint documentation
11. Participate in projects and events
12. Complaint determination
13. Reportability assessments
14. Conduct follow-ups with complainants and reporters
15. Check your own work
16. Update SharePoint
17. Track complaints in the process for closure
18. 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.