• Ensure the quality management system implementation and maintenance in accordance with ISO 9001 standards, GDPMD and Malaysian Medical Device Authority Regulations Act 2012.

• Develop and establish policies and standards that convey the best practices in the company.
• Responsible for managing and maintaining documentation related to quality management system.
• Liase with accredited certification body to carry out ISO and GDPMD audits and follow-up with relevant stakeholders to ensure the corrective actions are closed effectively.
• Maintain company Risk Register, coordinate Risk Management Meeting and conduct regular review with respective owners.
• Keep abreast on new regulatory requirement and ensure internal guidelines are in compliance.
• Collaborate with other departments and external parties to resolve quality problems and implement corrective actions.
• Assist in executing field corrective actions/recalls/reporting of medical devices malfunctions and adverse events.
• Support the regulatory affairs department on other work assignments from time to time.

• A Diploma / Degree in Biomedical, Medical Science, Pharmacy, Quality Management or equivalent.
• Minimum 3 years of working experience in quality management and/or regulatory experience in healthcare or medical device industry.
• Familiar with Medical Device Act (MDA), Good Distribution Practices for Medical Devices (GDPMD) requirements and ISO 9001 standards.
• Preferably with ISO and/or GDPMD internal auditor certification.
• Good in business writing and attention to detail.
• Ability to communicate effectively with all stakeholders and external parties.

An attractive remuneration package will be offered to the successful candidate.

Sysmex (Malaysia) Sdn Bhd
11A & 15 Jln PJS 7/21, Bdr Sunway, 47500 Subang Jaya, Selangor
Email : [email protected]

Only shortlisted candidates will be notified.