Quality System Engineer
Essential Job Functions and Accountabilities:
Establish and optimize ISO 13485 Quality Management System. Harmonize standard of process in different sites to satisfy business growth. Plan for internal audit, management review and drive QMS improvement Facilitate corporate, customer and certification body audit, manage closure of noncompliance. Maintain quality metrics and data analysis Enhance QMS through lessons learn summary and training delivery Manage Engineering change approval and implementation Manage calibration system Ensure CAPA effectiveness and escalation through regular CAPA review board deployment
· Bachelor, or above, Degree in engineering majors
Quality tool application, eg. FMEA, Control Plan, 6 sigma, SPC, etc.
5~8 years' experience in quality relative job, 3~5 years quality system experience. Familiarity with ISO 13485 quality system, regulatory such as FDA, IVDD, CFDA. Medical device industry QA/RA background is high preference. Experience in a manufacturing organization. Self motivated individual, possessed a mature and responsible nature. Mature presentation skill Excellent communication and team work spirit Good English skill both in oral and written is essential.