Quality management specialist

2 months ago


Subang Jaya, Selangor, Malaysia Sysmex Full time

Roles & Responsibilities:

  • Ensure the quality management system implementation and maintenance in accordance with ISO 9001 standards, GDPMD and Malaysian Medical Device Authority Regulations Act 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 Bhd11 A & 15 Jln PJS 7/21, Bdr Sunway, 47500 Subang Jaya, Selangor


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