รายละเอียดงานResponsibility:
1. Responsible for organize and manage the documentation to support projects in order to optimize the efficiency of the organization complied with ISO requirements/Regulations before product released.
2. Responsible for planning, executing and developing training courses about ISO requirements/ regulations for the manager and employees.
3. Responsible for review product labels/artwork for compliance with regulations ISO requirements/ Regulations. 4. Responsible for all FDA-related documents both import and manufacturing of medical device for submission/ permission. 5. Responsible for conduct support other regulations/Certificate/licenses/reword both domestic and international to product advantage.
6. Responsible for obtain renew regulations/Certificate/licenses/reword on timely manner
7. Handling customer questionnaires/specification on timely manner
8. Respond to customer/regulatory queries within pre-defined timelines
9. Responsible for perform the Post market Surveillance documents to ensure that accordance with the quality management system.
10. Responsible for support the FMEA, Risk management report, Design control and Internal audit team.
คุณสมบัติผู้สมัคร - Bachelor’s degree in Engineering, Sciences or Pharmaceutical Sciences.
- Strong knowledge of Computer-MS Office/Internet
- Understanding of Quality System (QS) Regulation/Medical Device, and MDR 2017/745.
- Comprehensive knowledge of Risk Management (FMEA), Change control process, CAPA process, Validation and Statistical Technical.
- Good coordination with Thai FDA regulations (Medical device control division).
- Good skills for team management, communication and collaboration with others department.
- Experiences of quality or production process in Medical devices /Pharmaceutical at least one year or working in the registration of medical devices at least one year.
- Experiences and knowledge in FMEA risk assessment, Change control process, CAPA process, Validation and Statistical Technical at least one year.
- Strong background within a Quality System/GMP/GDP/ISO13485/ ISO 14971/21 CFR Part 820/CE Mark/(MDR)/ISO9001.
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