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.
Medical Device Complaint Specialist (temporary)
Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Maintains and completes complaint file...
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Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Maintains and completes complaint file...
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Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed. Ensures compliance with all federal and international regulations applicable to manufactured medical devices. Maintains and completes complaint file...
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