Talent Elite Group
Complaint Specialist (Medical Device)
Talent Elite Group, Irvine, California, United States, 92713
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
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.