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QMS OFFICER

QMS OFFICER

YPC MalaysiaKlang City, Selangor, Malaysia
4 jam yang lalu
Penerangan pekerjaan

Responsibilities

  • Assist the QMS / QA Lead with follow-up and monitoring of ISO 13485 system implementation.
  • Implement and monitor the Quality Management System (ISO 13485 : 2016).
  • Prepare the audit plan and schedule for ISO 13485 : 2016.
  • Maintain and improve quality system procedures and policies.
  • Support the QMS / QA Lead in internal and external audits, including supplier audits.
  • Follow up on corrective action requests and conduct follow-up audits to verify effective implementation (IQA, system audits, and external audits).
  • Monitor equipment / tool calibration schedules and validation. Prepare calibration schedules, budgets, and specimen plans.
  • Prepare management review minutes in compliance with ISO 13485 : 2016 requirements.
  • Follow up on specimen testing and results for the Medical Division.
  • Participate in internal 6S implementation and improvement activities.
  • Act as Document Control Change (DCC).
  • Prepare monthly and mid / annual reports on QMS activities and present them to top management.

Qualifications

  • Diploma or higher qualification.
  • Minimum 1 year of experience in the manufacturing industry.
  • Proficient in Microsoft Office applications.
  • Proficient in process design, optimization, and troubleshooting.
  • Strong analytical and problem-solving skills.
  • Excellent communication and collaboration abilities.
  • Familiarity with ISO 13485 : 2016 Audits.
  • Knowledge of relevant industry regulations and safety standards.

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    Officer • Klang City, Selangor, Malaysia