苏州招聘

Principal Responsibilities*

1. Update validation system document or guideline for SZ3.

2. Review and approve related validation document in SZ3, including the validation plan/protocol/report/deviations. Work with project team to conduct the validation and perform the data analysis. Communicate any problems occurred in validation documents or activities with project team in time.

3. Tracking validation compliance with VMP schedule.

4. Maintain the Validation training and certification plan for SZ3.

5. Communicate the validation issues with global validation team.

6. Provides for the management of all supplier related activities.

7. Critically important to this function is ensuring quality products from OEM suppliers, working through potential product issues / changes with the OEM suppliers

8. Provide the ability to support quality systems using Six Sigma tools for existing suppliers.

Education/Experience/Skills/Training*

1. BS degree in engineering discipline, MS preferred.

2. Minimum of 5 years’ experience in manufacturing preferably in medical device or pharmaceutical. Three year experience as a validation engineer required.

3. Experience with FMEA / Risk Management, mold and process validations, control plans and MSAs required.

4. Six Sigma Certification preferred Green Belt minimum

5. Lead Auditor training and knowledge of advanced audit practices preferred

6. Medical Device industry experience and knowledge of FDA/ISO 13485/QMS/cGMP regulations.

7. Familiarity with the use of ERP/Document Control systems (e.g. SAP, TrackWise).

8. Good planning and execution

9. Excellent verbal & written communication skills

10. Good English skills both reading and writing.

Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.