形容
SECTION 1: JOB SUMMARY*
- Perform various technical duties of quality control and quality assurance such as: Establish quality procedures and test method for raw materials, in-process and finish good.
- Perform quality control and quality assurance for product transfer and BWI Carto product manufacturing process.
- Work scope covers BWI Carto product in Ethicon Suzhou site.
SECTION 2: DUTIES & RESPONSIBILITIES*
Under and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
o Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.
o Maintain and improve incoming, in-process quality control, finish good release procedure, provide technical support of process validations and risk management control.
o Draft quality procedures and test method for raw materials, in-process and finish good.
o Responsible for inspection instrument qualification and test method validation.
o Provide Q uality support in Product transfers and new products development.
o Perform investigation of NC, CAPA, complaint investigation as needed;
o Review NCR and disposition of nonconforming products.
o Assist in training of production and inspectors on quality knowledge.
o Participate in process/quality improvement projects.
o Support COGs initiatives.
o Responsible for following and administering safety.
o Compliance with safety policies and procedures.
o Follow J &J and Ethicon Records Management Policies for Convenience information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and the third-party vendor if applicable.
o Provide as needed, subject matter expert feedback on manufacturing process changes.
o Responsible for communicating business related issues or opportunities to next management level.
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
o Performs other duties assigned as needed.
資格
SECTION 3: EXPERIENCE AND EDUCATION*
- Bachelor's degree and above in chemical, mechanical or pharm preferred.
- 3-5 years related work experience or demonstrated performance.
- Experience in electrical, medical device and pharm industry.
SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
- Six Sigma Green Belt preferred.
- Fluent in oral English is preferred.
- GMP/ ISO knowledge preferred.
- Good communication skill and teamwork spirit.