Complaint Specialist

4 weeks ago


Irvine, United States Talent Elite Group Full time

Seeking a detail-oriented and knowledgeable Medical Device Complaint Specialist to join our quality assurance team.


The successful candidate will be responsible for full-cycle handling and investigating complaints related to our medical devices, ensuring compliance with regulatory standards, and maintaining high quality and safety standards for our products.


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.


QUALIFICATIONS

- 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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