Key Responsibilities:
• Quality System Management:
Develop maintain a robust quality system to ensure regulatory compliance continuous improvement.
1. Coordinate documentation management to ensure the efficiency of the quality system.
Conduct regulatory intelligence to monitact on relevant laws standards.
• Quality Assurance:
Manage quality control functions operational permissions of computer information systems.
1. Review dynamically manage the qualifications of medical device suppliers, products, purchasers.
Confirm supervise the handling of non-conforming medical devices.
1. Coordinate the verification calibration of relevant facilities equipment.
Implement UDI to ensure medical device traceability.
• Post-Market Surveillance:
Investigate, handle, report medical device quality complaints incidents.
1. Manage medical device recalls quality safety risk consultations.
Collect report adverse events related to medical devices.
Qualifications:
• Bachelor’s degree in medical device, life science, chemistry, a closely related field.
• Over 5 years of professional experience in quality management within the medical device industry.
• In-depth knowledge of GSP, ISO 13485 regulations.
• Proficient in English (bothal written).
• Demonstrated ability to manage people with strong interpersonal skills fcollaborating across teams working with interested parties.