Philips Quality Engineering Manager in Shenzhen, China

Your Responsibilities:

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

Experience:

  • 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.