北京招聘

Main Purpose:

1. Interprets government regulations as they apply to products, processes, practices and procedures to anticipate and integrate regulations changes into Chengdu.

2. Coordinate and support the organization during external audits

3. Coordinate answers to agencies and associated CAPA plans

4. Lead the Quality System team to support Chengdu organization.



Key Accountabilities:

1. Provide guidance and direction to Chengdu to ensure the compliance to Quality System Regulation and ISO Standards.

2. Lead and provide coaching / guidance to the Quality System team to ensure the effectiveness of key quality system processes and continually improve these processes. Establish individual performance & development objectives / plan for Quality System team members.

3. Participate in the CVG harmonization in close collaboration with all departments personnel to define adoption strategies

4. Evaluate and perform assessment on the Product Change Request for manufacturing changes.

5. Coordinate change approvals through Regulatory and Reliability.

6. Interprets government regulations

1) Understand regulation’s intent applying for Chengdu

2) Anticipate regulation trend and knowledge to keep Chengdu 100% compliant

3) Provide global analysis and propose integration strategy to Chengdu Compliance management

4) Integrate new requirements and regulations changes into Chengdu QMS

5) Update Chengdu documentation/procedures accordingly

6) Provide coaching to business partners for Compliance topics

7. External audit preparation / coordination

1) Establish the preparation program involving all Chengdu partners

2) Performs the coordination and preparation of external audits

3) Thorough action plan progress check and raise any out of control situation

4) Provide a clear picture to Chengdu management before inspection

5) Ensure external audits logistics

6) Participate to external audits/inspections as Chengdu Quality Compliance expert

7) Support Chengdu auditees in providing the necessary documentation for the external auditors

8. Agencies answers and associated Quality Systems

1) Provide the necessary input / answer to regulatory agencies on Chengdu Quality System processes and work with Chengdu business partner to ensure timeliness and accuracy of information provided.

9. Back-up

1) In case of needs to be backed up : This role backup the Quality System Specialist and Senior Quality Engineer (Change Control)

2) Is the back up if needed: This role is backed up by the Senior Principal Quality System Specialist.



Attributes:

1. Takes initiative and demonstrates leadership

2. Task oriented and result driven

3. Flexibility and adaptability

4. Analytical skills

5. Persuasive, open minded and active listener

6. Teamwork skills

7. Tenacity and engagement, patience and perseverance



Experience and Knowledge:

1. Minimum 6-8 years’ experience of Quality System management and exposed to ISO, PMDA, FDA and other regulatory agency inspections

2. Quality Assurance Specialist, Quality System Management Specialist or equivalent is an asset

3. Experience in a medical device company or equivalent will be advantage

4. Change management and GMPs experience

5. Good communication skills

6. Proven evidence of The Medtronic Traits:

1) Global

2) Mission values

3) Compliance and Integrity

4) External focus

5) Clear thinking

6) Driven to win

7) Inspires others

8) Executes

9) Boundaryless



Qualifications:

1. Bachelor Degree in Science in Biomedical or Engineering or equivalent

2. Fluent in English language

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