What are the responsibilities and job description for the CAPA & Complaint Specialist position at Altimate Medical Inc?
The CAPA and Complaint Specialist supports the Quality & Regulatory department in receiving and processing complaints and corrective/preventive actions in the Quality Management System (QMS). It will include reviewing Device History Records, performing Risk Analysis, conducting and assisting with investigations, root cause analysis, and maintaining accurate records. The role will also be to collaborate with other departments while conducting the activities.
ESSENTIAL FUNCTIONS
- Provide corrective/preventive action and customer issue/complaint support for Class I and Class II medical devices in US and global markets for the family of AMHI companies.
- Customer Issues/Complaints
- Review customer issues/complaints
- Follow up with initial reporters for additional complaint information as required
- Ensure timely processing of complaints including medical device reporting decision trees and complaint investigations within required timeframes
- Collaborate with other departments, as applicable, during complaint investigations
- Communicate any adverse events/reportable incidents to the Regulatory Compliance Specialist and Director.
- Corrective and Preventive Actions
- Define the problem, contain the problem, identify the root cause, and determine the corrective action plan
- Liaise with other departments as applicable to the issues
- Perform activities within required timeframes
- Risk Management
- Consider the impact of issues/complaints and corrective/preventive actions on risk.
- Update risk files as needed.
- Collaborate with QMS Team members to identify improvement opportunities and develop solutions.
- Participate in internal and external audits or inspections on CAPA and Customer Issue/Complaint related matters.
- Participate in meetings providing data analysis on CAPA and Customer Issue/Complaint information.
- Other tasks and responsibilities as assigned. This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
- Understands and adheres to Quality & Compliance policies and procedures.
- Follows safety procedures and maintains a clean and safe work environment.
