HireDiversity

Suzhou, CN

Quality Engineering Manager-Su Zhou-0000098J

Description

o Management of the Quality Engineering team with regards to work assignments, continuous training and Quality Engineering Documentation
o Set objectives and give input to Quality Engineering performance ratings

o Assure a Lead Quality role in transfer of product to Suzhou, resolve problems and expedite information exchange to meet product transfer targets
o Use judgment and experience to make decisions regarding acceptability of product and Quality System documentation e.g. Deviations - Engineering Changes
o Develop the Quality Engineering team in Suzhou in order to provide them full expertise, autonomy and compliance with DePuy and J&J requirements.
o Identify opportunities to continually improve Quality Engineering cost and time factors, consistent with the plant Business Objectives
o Ensure Quality Engineering personnel is aware of "State of the Art" Equipments and Technologies
o Ensure the Site Validation Master Plan is complete and up to date and all validation and verification activities are completed correctly in a timely manner
o Actively participate in product and problem resolutions e.g. Product Field Actions, Product Complaints and Regulatory Inspections / Audit non-conformances
o Participate in the Suzhou Management Team and the Quality teams e.g. Management Review, Production meetings, Internal Audits etc…
o Conduct internal and external quality audits at a Lead Auditor level as required.
o Propose, develop and implement programs to improve quality, scrap rates, lead times, or any other program defined by the management
o Develop and implement required procedures, which should permit integration with other MD&D franchises.
o Perform job duties in full accordance with:
- All J&J policies on Information, Assets protection, Maintain password(s) confidential, protect critical Business Information
- All J&J policies and local regulations
- All policies of the Health Care and Environmental programs
- The code of conducts
o Full responsibility and ownership (like all employees on site) for all audits (internal, Corporate, External, for Quality, H&S, Environment, etc…)

Qualifications


? Experience with working within a DePuy JTE Workshop
? 5 plus years of experience as Quality Engineer in a medical device, pharmaceutical or similar regulated industry
? 2 plus years of people management experience
? Experience in auditing to both FDA QSR and ISO 13485 standards.
? Expert knowledge of Good Manufacturing Practices, regulations and validation methods.

Primary Location:Asia Pacific-China-Jiangsu-Suzhou
Organization: Johnson & Johnson Medical Suzhou Ltd. (7054)
Job Function: Quality (Generalist)