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
Supplier Quality Engineer - (M/F)
to be responsible for representing supplier quality in product development projects and supplier management.
Your main tasks and responsibilities:
You will responsible for providing supplier quality expertise as well as creating, reviewing, and approving supplier quality documentation to ensure compliance with internal procedures and regulatory requirements for in-vitro diagnostics and medical devices.
You will manage quality and supplier quality engineering process and will utilize his/her prior experience in both supplier management and quality engineering in the IVD industry to develop and maintain key processes, while adhering to regulatory requirements
You will be responsible for providing adequate level of oversight with suppliers and OEMs, as well as ensuring that procurement, product development, and manufacturing processes are meeting business goals and quality standards.
You will develop relationships and interfaces with suppliers to maintain positive performance and hold suppliers accountable when business or quality needs are not met
You will ensure supplier audit and Supplier Corrective Action Request (SCAR) processes are implemented effectively
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 (Engineering, Molecular Biology or Biochemistry preferred)
4+ years’ experience in a supplier quality engineering AND/OR design/manufacturing quality engineering role at a IVD or MD Manufacturer
Knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements
Lead Auditor experience per ISO 13485 and/or FDA QSIT audits is consider as an asset
Your attributes and skills:
You are a driven individual with a history of developing collaborative, cross-functional solutions
You have highly developed writing and interpersonal skills with the ability to work with international teams
You have working knowledge of common computer software applications (SharePoint, SAP, WORD, EXCEL, Adobe Acrobat, etc)
You have excellent written and spoken English language skills
You have capacity for working independently and excellent interpersonal and organizational skills
You are willing to travel +/- 30%
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/
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time