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: Bachelors 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