Complaint Resolution Specialist

4 weeks ago


Irvine, California, United States Talent Elite Group Full time

Job Summary

Talent Elite Group is seeking a detail-oriented and knowledgeable Medical Device Complaint Specialist to join our quality assurance team.

Key Responsibilities:

  • Complaint Handling:
    • Receive, log, and track complaints related to medical devices from various sources such as customers, healthcare providers, and regulatory bodies.
    • Ensure each complaint is categorized accurately, prioritized, and investigated promptly.
  • Investigation:
    • Conduct thorough investigations to determine the root cause of complaints, involving relevant departments (e.g., engineering, manufacturing, clinical) where necessary.
    • Review product history, batch records, and other relevant data to gather information.
    • Document findings in clear, detailed reports.
  • Regulatory Compliance:
    • Ensure complaint handling processes and investigations comply with regulatory requirements (e.g., FDA, ISO 13485, EU MDR).
    • Prepare and submit regulatory reports, as needed, including Medical Device Reporting (MDR) and Vigilance Reporting.
    • Stay updated with changes in regulatory requirements and adjust processes accordingly.
  • Documentation and Reporting:
    • Maintain accurate and comprehensive records of all complaints and investigations in the complaint management system.
    • Analyze complaint data to identify trends and areas for improvement.
    • Generate regular reports and metrics on complaint status and investigation outcomes for management review.
  • Continuous Improvement:
    • Participate in cross-functional meetings to discuss complaint trends and potential corrective and preventive actions (CAPA).
    • Assist in implementing process improvements based on complaint analysis to enhance product quality and customer satisfaction.
  • Customer Communication:
    • Provide timely updates to customers regarding the status and resolution of their complaints.
    • Handle customer communications professionally, ensuring their concerns are addressed satisfactorily.

Requirements:

  • A minimum of 2-4 years of experience in complaint handling, quality assurance, or a related field within the medical device industry.
  • In-depth knowledge of medical device regulations and standards (e.g., ISO 13485)
  • Proficiency in using complaint management systems and quality management software.


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