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.

As member of the China Project team, the primary responsibility for this role will be assisting QA manager and Core Team Quality Lead with the development and implementation of the China facility Quality System.This position also will assist in the Quality Assurance Management System building-up and operation to ensure the system is comliance with all domestic and global regulatory and corporate requirements.
?Integration of Siemens Healthineers global and Walpoles quality system requirements into China facility quality system that is compliant with CFDA requirements, with an emphasis on the following QMS processes:
oCAPA
oInternal audit
oChange Management
oManagement Review
oQuality Continuous Improvement
?Provide support to the China Quality team to ensure that the Quality Management System is fully implemented in the organization according to Project Plan.
?Interact with relevant regulatory agencies and assist in the regulatory agency inspections, participate in acquisition of Manufacturing license application, maintenance and renew.
?Assist in other quality activities assigned by QA Manager, such s support GMP related training organized by Training Department.
?May require some travel to U.S.

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.

?EDUCATION:
oBachelor’s Degree (or equivalent degree).

?EXPERIENCE:
oAt least 3 years’ working experience in the pharma and medical device industry.
oPrior experience working in a CFDA regulated environment.
oPrior experience with facility start-ups, or other major projects, e.g. quality system remediation efforts or deployment projects is perfered.

?REQUIRED SKILLS:
oExcellent understanding and practical application of medical device quality system regulations including CFR 21 Part 820 (QSR), ISO 13485, CFDA Regulation , and other domestic and international regulations that may apply.
oExcellent verbal and written communication skills.
oMust be able to work collaboratively with other project team members.
oFluent in English
oKnowledge of CFDA IVD GMP requirements