QMS OFFICER

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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