Quality(Senior/Staff) Engineer

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.

Qualifications

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.