Job Responsibilities

Work hours per week: 40 Job link: http://www.pchintl.com/careers/open-positions/quality-system-manager/ Email: hr@pchintl.com

Job Requirements

REQUIRED QUALIFICATIONS, EXPERIENCE & KEY SKILLS Requirements include: University graduate at least with minimal 8 years working experience Sound experience in quality/environmental management system setup, maintenance or auditing include ISO9000 family and not limited. Experience of medical device quality system ISO13485 is preferred, and experience of FDA factory inspection experience Familiar with cGMP process and FDA CFR Part 820 and it extended requirement Familiar with QSIT technology Other quality system knowledge is a plus (TS16949, TL9000, AS9100 etc.) Experience of maintenance and structure of product life management software (Agile , Winchill or other similar tools) Experience of manages of a document center

Required Languages