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.
Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.
Your tasks and responsibilities:
- You will independently lead Siemens Healthineers-wide improvement projects to ensure regulatory compliance and strengthen our competitiveness in all areas of the QM system
- You will independently develop new QM concepts to support Siemens Healthineers units (Business Areas, Business Lines, Functions, Countries) in the implementation of international regulatory and Siemens Healthineers internal requirements.
- With a focus on software development, you will be responsible for developing and communicating "best practices", "lessons learned" and other variants of applied knowledge management. In doing so, you will lead the relevant teams and draw on your in-depth experience in software development.
- You are the expert contact for UDI (Unique Device Identification) and label requirements and support the business areas, business lines and countries in the implementation of these. You will lead the definition of global specifications and central coordination committees.
- You perform inspections, compliance audits and quality assessments to ensure global market access for medical devices and in-vitro medical devices
- You optimize and create processes, guidelines and quality requirements for Siemens Healthineers as a whole, independently create appropriate trainings and conduct them
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services.
Your qualifications and experience:
- You have a university degree in a scientific or comparable field (e.g. medicine, pharmacy, medical technology).
- You have many years of professional experience in the field of quality management for medical devices; practical experience and knowledge of the development process, especially for software products, are a prerequisite
- You already have many years of sound professional experience and further qualifications in this field, but no degree? Then we are also looking forward to your application
- You have a good knowledge of UDI (Unique Device Identification) and/or label requirements worldwide
- You also have very good knowledge in the area of improvement processes (e.g. CAPA), have experience in the creation of concepts and guidelines and you are familiar with the risk management of medical devices according to ISO 14971.
- You stand out due to your knowledge of relevant QM requirements in medical technology (ISO standards, laws), have practical experience in auditing (QSR, ISO, GMP) and can ideally demonstrate certification as an auditor according to ISO 19011
Your attributes and skills:
- You are future-oriented and enthusiastic about aspects such as digital health and digitalization
- You have the ability to analyze complex issues, process them in a structured manner and communicate them to third parties
- You bring along a willingness to travel within the scope of global improvement projects and audits
- Confident presentation and communication skills in English and a good command of German, a very independent way of working and working in partnership at the interfaces with the Siemens Healthineers units round off your profile
Our global team:
Siemens Healthineers is a leading global medical technology company. 66,000 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.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is
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Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
Organization: Siemens Healthineers
Company: Siemens Healthcare GmbH
Experience Level: Experienced Professional
Job Type: Full-time