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QMS OFFICER
YPC MalaysiaKlang City, Selangor, Malaysia5 hari lalu
Penerangan pekerjaanDiploma 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.
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
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Officer • Klang City, Selangor, Malaysia
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