Competency Requirement
- Bachelor of Engineering or equivalent or higher
- 10 years’ experience in Quality Assurance
- 5 years’ experience in QMS such as MDR, EN ISO 13485, FDA 21 CFR 820
- Certified ISO 13485 Lead Assessor
Responsibilities
- Perform activities related to the documentation of Quality Management System (QMS) and ensure relevant processes and activities are in compliance with ISO13485,MDD 93/42/EEC,FDA21 CFR820, and other statutory
- Responsible for document control;
- Prepare and co-ordinate both internal/external (including supplier) audit;
- Provide QMS support to cross-functional terms, and ensure execution and effectiveness of key quality system process;
- Ensure design changes are tracked and process change requests in a timely manner;
- Manage non-conformities (product and process) and track progress of resulting corrective action preventive action
- Manage Customer Complaint and track complaint Closure
- Update Device Master Record (DMR)
- Update QMS Document (Quality Manual, Quality Procedure and SOP)
Please attached complete CV for all candidates
