JOB RESPONSIBILITIES
- Establish and maintain QMS and ensure compliance to regulatory requirements
- Manage compliance with ISO 13485 and relevant county/regional regulations
- Performing Internal Audit to verify compliance and conformance to quality system requirements
- Engage in External Audit Processes (Notified Body, Corporate, Regulatory, etc)
- Prepare Audit Plan and related Audit Checklist
- Lead Non-Conformance and CAPA processes related to manufacturing and internal / external audit
- Follow up on internal / external corrective actions to ensure timely implementation and validate the effectiveness
- Stay up-to-date on New/Revised Regulations, Standards, Policies and Procedures
- Promote quality awareness amongst all employees
- Perform any other related duties as assigned by immediate superior
JOB REQUIREMENTS
- Education level: Minimum Bachelor's degree in Chemistry or Engineering (or any relevant discipline)
- Year Experience: Minimum 5 years’ experience in medical device or pharmaceutical industries
- Effective communication and organizational skills
- Possess knowledge of ISO 13485 and general GMP related regulatory requirements
- Report to: Quality Manager