Quality Assurance

2 weeks ago


Kuala Selangor, Selangor, Malaysia MEDIDATA SDN BHD Full time

JOB DESCRIPTION

  • Ensures the compliance to ISO 13485, ISO 9001, Good Distribution Practice for Medical Device (GDPMD) standards and any other relevant regulatory standards at all times.
  • In charge of prepare, review, implement, and maintain the ISO 13485 and ISO 9001 quality management system, as well as the GDPMD regulatory compliance system.
  • Part of Risk Management Team & Post Marketing Surveillance Team.
  • Evaluates audit findings and implements appropriate corrective actions. Investigates, plans and monitors the corrective and preventive action plan.
  • Handles all internal audit and external audits, customer and regulatory audit needed by Company.
  • Ensures ongoing compliance and uptodate with quality standards and industry regulatory requirements.
  • Performs random testing and inspection for incoming stocksand finished products. Collects, compiles, and analyses statistical quality data.
  • Liaises with the external parties including government body and certification body on matters relating to the Malaysian medical device regulatory requirements.
  • Assists superior to ensures validity and ontime renewal of ISO certifications, GDPMD certifications and CE marking with the relevant Authorities.
  • Prepares reports to communicate outcomes of quality activities. Investigates customer complaints and internal nonconformances of materials and finished products.
  • Assists superior in identifying and planning necessary trainings for the personnel involved in the supply chain activities/operations and period the training to satisfy these needs.
  • Carries out other tasks or projects being assigned by the Management from time to time.

JOB REQUIREMENT

  • Preferably a Bachelor's Degree in Engineering, Biomedical Science, Medical Science or any other related studies.
  • Knowledgeable in ISO 13485, ISO 9001 and GDPMD.
  • Working experience in QA QC is an added advantage.
  • Good command in English and Bahasa Malaysia both in written and spoken.
  • Positive working attitude and resultoriented person.
  • Team player and also able to work independently with minimum supervision.
  • Healthy and selfmotivated person.

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