Quality Management Specialist
3 weeks ago
**Roles & Responsibilities**:
- 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.
**Requirements**:
- 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.
**Sysmex (Malaysia) Sdn Bhd**
11A & 15 Jln PJS 7/21, Bdr Sunway, 47500 Subang Jaya, Selangor
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