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.
