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
Quality Team Leader (M/F)
Your main tasks and responsibilities:
• You will act as a Team leader and manage a small team of quality engineering professionals
• You will manage the Supplier Quality management process, including supplier audits and SCARs
• You will provide coordination of quality procedures, instructions, specifications, and standards to ensure conformance to ISO 13485 and IVD Regulation (EU) 2017/746
• You will own the product risk management process as per ISO 14971
• You will establish QE team as trusted business partner for R&D, SCM and CRM colleagues
• You will act as quality coach providing guidance throughout new product development, manufacturing, and post-market processes, including product and process changes
• You’ll be responsible of the implementation of Design and Development and Risk Management requirements into product development processes
• You will create and maintain related quality documentation to support product development, e.g., ensure adequacy of verification and validation records for all new products
• You’ll actively participate in product development core teams, e.g., provide input from a quality engineering and risk management perspective
• You’ll bee an active promoter of quality mindset throughout the organization
• Travel activity if required.
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Your qualifications and experience:
• You have a MS degree in relevant area, e.g. engineering, biology, chemistry, biomedical sciences or similar by experience. PhD is preferred
• You have knowledge of PCR, a molecular background or experience in the IVD business
• You have at least 5 years of experience in Quality or R&D department
• You have in-depth working knowledge of ISO 13485 and ISO 14971
• You have a proven track record of successfully leading small team in medical device environment
Your attributes and skills:
• You have excellent interpersonal and organizational skills
• You have a working knowledge of common computer software applications (WORD, EXCEL, Adobe Acrobat, etc.)
• You have excellent written and spoken English language skills, knowledge of French and/or German language is an asset
• You are willing to work in an international team within a highly collaborative environment
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.
Organization: Siemens Healthineers
Company: FAST TRACK DIAGNOSTICS LUXEMBOURG S.à r.l.
Experience Level: Experienced Professional
Job Type: Full-time