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Quality Management Specialist

Sysmex (Malaysia) Sdn Bhd | Subang Jaya | MY

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If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information Quality Management Specialist - Sysmex (Malaysia) Sdn Bhd below matches your qualifications. Good Luck: D

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

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.
An attractive remuneration package will be offered to the successful candidate. Interested candidates are welcome to write-in or email your resume with contact telephone number and a recent passport sized photograph to the following:

Sysmex (Malaysia) Sdn Bhd
11A & 15 Jln PJS 7/21, Bdr Sunway, 47500 Subang Jaya, Selangor
Email : hr@sysmex.com.my

Only shortlisted candidates will be notified.

Information :

  • Company : Sysmex (Malaysia) Sdn Bhd
  • Position : Quality Management Specialist
  • Location : Subang Jaya
  • Country : MY

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Quality Management Specialist job info - Sysmex (Malaysia) Sdn Bhd Subang Jaya above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Quality Management Specialist job info - Sysmex (Malaysia) Sdn Bhd Subang Jaya in 13-05-2024 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

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Post Date : 13-05-2024

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