JOB DETAILS

JOB DETAIL

- Oversee and ensure effective implementation of change control procedures.
- Handle non-conformances (NC) and corrective and preventive actions (CAPA) from raw materials to finished products.
- Manage all aspects of quality assurance for suppliers to ensure compliance with standards.
- Oversee the management and maintenance of the document control system.
- Handle local regulatory affairs matters to ensure compliance with relevant regulations.
- Manage internal and external audits to ensure compliance with quality standards.
- Lead a team of 7 engineers and officers to ensure the effectiveness and efficiency of our quality assurance activities.

REQUIRED WORK EXPERIENCE

- Bachelor’s degree in Science, Engineering, or related field.
- 8+ years of experience in Quality Control or QA in medical devices, pharmaceuticals, or other regulated industries.
- Strong knowledge of ISO 13485, ISO 14971, and regulatory standards.
- Experience leading teams in laboratory testing, inspection, and calibration functions.
- Excellent problem-solving, risk analysis, and decision-making skills.
- Fluent in English (written & spoken), with strong cross-functional communication ability.