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SHDM Senior Quality Engineer

Job Description

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

 

Then come and join our global team as EHS Manager to be responsible for biosafety, chemical and hazardous materials use, hazardous and biological waste management, emergency response, and ergonomics for manufacturing/laboratory environments.

 

Your tasks and responsibilities:

 

•Leading or participation on  validation and qualification activities, such as SVMP, validation protocol and report, execution monitoring for process, 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 to ensure that processes are appropriately qualified/validated in a timely manner.     

•Leading or participate on design historical files transfer activities from sending site to receiving site; coordinating design review/manufacturing transfer review; reviewing and consultant for design change.

•Leading or participate on risk files transfer activities from sending site to receiving site and drafting activities for process, equipment, facility; reviewing and consultant quality case(nonconformity and change) risk analysis.

•Leading establishment on process of post-market quality activities, such as complaint, Field Actions, Adverse Event etc).

•Other related projects or tasks assigned by superior or company.

 

 

 

To find out more about the specific business, have a look at https://www.healthcare.siemens.com.cn/

 

Your qualifications and experience:

 

•A minimum of 5 years in medical device , biotechnology or pharmaceutical industry, with a Quality Engineer role.  Majority experience in at least 3 of 5  areas and have some experience or knowledge of other two.

•Individualy handling Quality Engineer activities in at least 2 areas and have experience of activities in other area with guideline from others.

•Have product transfer experience or manufacturing establishment experiences are preferred.

 

Our global team:

 

Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

 

Our culture:

 

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

 

Check our Careers Site at www.healthcare.siemens.com.cn/careers.

 

As an equal opportunity employer, we welcome applications from individuals with disabilities.

 

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started. 

 

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

 


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Manufacturing Ltd., Shanghai

Experience Level: Experienced Professional

Job Type: Full-time

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