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
QM scientist - (M/F)
to review and approve documentation for compliance with EU, and other international regulations.
Your main tasks and responsibilities:
You will Identify and manage areas of potential noncompliance (Process quality deviations CAPAS)
You will be responsible for monitoring and further development of the QM System according to ISO 13485:2016 and regulatory requirements in accordance with the IVD guidelines
You will write and review relevant documentation
You will be deputy of HoD QS&C for Change control Process
You will act as Safety Officer
To find out more about the specific business, have a look at http://www.fast-trackdiagnostics.com/
Your qualifications and experience:
Minimum BA/BS in scientific discipline
Good understanding and knowledge of ISO 13485:2016, ISO 14971, IVDD 98/79/CE, Canadian regulations, FDA regulations, (other regulations would be considered as a plus)
Experience in RT-PCR is an asset
Your attributes and skills:
You have a good knowledge of MS office
You are fluent in English both writing and speaking; any other language is considered as an advantage
You are able to communicate in a clear, concise and timely manner.
You are very well organized, including attention to detail, but flexible in thinking
You have the ability to stick to timetables and work under pressure
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 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 http://www.fast-trackdiagnostics.com/about-us/career/
Job ID: 189368
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time