Quality(Senior/Staff) Engineer
SECTION 1: JOB SUMMARY
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• 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
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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.
SECTION 3: EXPERIENCE AND EDUCATION
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• 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
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• Six Sigma Green Belt preferred.
• Fluent in oral English is preferred.
• GMP/ ISO knowledge preferred.
• Good communication skill and teamwork spirit.
- Rate: Not Specified
- Location: Suzhou, CN-32
- Type: Permanent
- Industry: Finance
- Recruiter: Johnson and Johnson
- Contact: Not Specified
- Email: to view click here
- Reference: 2406208944W
- Posted: 2024-08-29 08:09:03 -
- View all Jobs from Johnson and Johnson
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