QMS Engineer

• Maintaining and improving company management system, working together with each department to establish and update system documents.
• Monitoring quality system operation, conduct and follow suggestions.
• Overseeing quality management system operation status.
• Planning and organising internal audit, following the corrective action and the verification.
• Handling the system promotes and carries out an execution.
• Handling the internal publicity and training of quality management knowledge.
• Handling the external audit and customer audit follow.
• Handling product certificates and system certificates, internal auditor assessment and training.
• Being in charge of calibrating and maintaining the measurement equipment or device.
• Drawing up operation/maintenance instructions or measuring devices and equipment in the department.
• Drawing up an annual calibration plan and following the plan to ensure the calibration is done.
• Managing measurement devices, calibration and maintenance.
• Deal with other assignments assigned by the superior.

• Bachelor degree in Engineering or Science.
• Above 4 years relative work experience in QC/QA or similar in the medical device industry.
• Excellent problem-resolution, judgment, and decision-making skills are required with thorough working knowledge of QC tools, methods and practices.
• Experience/familiarity with regulated product quality system requirements, i.e. ISO 13485, FDA Quality System Regulations, ISO 14971, and other applicable standards.
• Good command of English in communication.
• Good command of MS Office software applications.
• Strong skills in teamwork, effective communication and ability to grow positive professional relationships.

PRTR