Philips Quality Engineering Manager in Shenzhen, China
As a quality team manager, leads team to
Understand and deploy processes to assure conformance to government regulations, industry standards and product specifications.
Review and approve process validation protocol and production related procedure.
Review environmental conditions records and respond to excursions
Work with Production Dept. to monitor production processes and resolve production quality issues.
Investigate, assess and close deviations, determine impact of the issues that could affect product quality, safety and effectiveness.
Work with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Operation activities.
Work with Quality system team, deploy Quality systems (e.g. CAPA, process control) to ensure products conform to defined requirements.
We are looking for:
Education: BS in engineering discipline or equivalent education
At least 8 years work experience in quality filed,
At least 3 yrs. work experience in medical device industry or high regulated industry.
At least 3 yrs. experience as a people manager role, supervisor or manager. Etc.
Competencies and skills:
Strong understanding of Quality System regulations (FDA, ISO13485).
Good understanding of statistical methods, quality tools and methodologies (SPC, FMEA, DOE, etc.)
Rich experience and skills in leading/managing a team
Well-developed organizational and analytical skills
Proven ability to lead diverse discipline teams, understand and identify relationships and interdependencies across multiple projects and initiate team building
Communicate globally, across teams and programs, from senior executives to administrative support personnel.
Both detail oriented and able to see big picture
Good command of both English and Chinese Language is a MUST.