We at Siemens Healthineers™ are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.

If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.

In this role the individual will be responsible for coordination of assigned Validation and Qualification activities including process, test method, equipment, facilities, and utilities of an IVD manufacturing facility to be built in China. Will work closely with the other project core team leads/functions, e.g., Manufacturing, Technical Operations, Engineering and Quality Assurance, to ensure that processes are appropriately qualified/validated in a timely manner.
Lead QE team and specific responsibilities include but are not limited to:
•Develop and maintain a site Validation Master Plan.
•Work with Engineering on specific equipment, facility and utility validation plans and reports.
•Ensure that all qualification/validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA.
•Recruitment and training of the China site Quality Engineering team
•Provide coaching and mentoring of China based QE personnel
•Lead the local validation review board and patriciate the change control review broad activities.
•Responsible for coordinating risk management activities in China including driving risk management reviews and updates.
•Handle all production related Non-conformance/Deviation from materials, process, and finished products.

This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.

•Experience:
A minimum of 7 years in the medical device (IVD), at least 2 years at a management level, with main knowledge in validation and risk management.

•Education:
A minimum of a 4 year degree is required.

•Skills/Knowledge/Experience:
oKnowledge of CFR 21 Part 820 (QSR), ISO 13485, ISO 14971, and other domestic and international regulations that may apply
oExtensive experience in the application of production and process controls including process validation, test method validation, process control plans, statistical process control, risk management and statistical tools.
oExcellent verbal and written communication skills.
oGood communication skill, Must be able to work collaboratively with other project team members.

•Preferred Knowledge/Skills, Education, and Experience
oPrior experience with facility start-up/qualification projects.
oA quality engineering certification from the American Society for Quality or other qualifying organization is highly desirable. Examples include the CQE, CRE, etc.
oFluent in English
oKnowledge of CFDA IVD GMP requirements

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