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Quality Assurance Manager Taipei

Taipei
2021-05-30 02:43:31
Quality Assurance Manager Taipei
THE POSITION:

The Quality Assurance Manager coordinates all activities involving development, implementation, and maintenance of quality management systems and compliance across all the Medical Devices / In Vitro Diagnostic Devices supplied by Life Technologies in Taiwan market.

Job Responsibilities:
• Lead and drive the establishment and maintenance of Quality Management System (QMS) according to ISO 13485 and TFDA GDP regulations.
• Coordinate with all the cross functional teams to comb and ensure all the processes and activities to meet with ISO 13485 and TFDA GDP requirements.
• Support Management Representative, lead and drive the Management Review Meetings and internal audits.
• Lead, drive and oversee the resource organization and activities coordination for external audits and regulated audits.
• Supply professional guidance or training to cross functional teams to implement quality assurance work, including quality documents and records.
• Lead the coordination of Complaint... Management, CAPA, NC Management, co-work with RA for Medical Devices / In Vitro Diagnostic Devices post market vigilance control.
• Other tasks assigned by line manager.

Minimum Requirements:
• Bachelor’s degree or higher degree in Engineering, Sciences, or related field.
• Over 10 years relevant experience in Quality Assurance related to Medical Device and/or In Vitro Diagnostic Device.
• Knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, TFDA GDP and other Regulatory as applicable.
• Auditor certificate or equivalent experience
• 3 years supervisory experience

Essential Skills and Abilities
• Strong planning and organizing management skills
• Skilful in communication, effective written, verbal and presentation skills in the area of Quality Assurance.
• Excellent analytical skills, results-oriented and a creative problem solver
• Ability to work effectively and collaboratively, across cultures and functions
• Able to work under pressure and flexible working hours based on business requirements
Taipei Taiwan
Quality Assurance Manager Taipei Thermo Fisher Taipei
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Mayflax Damansara, Petaling Jaya, Selangor, 46350 MY
Mayflax
Damansara, Petaling Jaya, Selangor, 46350 MY

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