Design Quality Assurance Specialist Varian (f/m/d)

Description du poste:

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. Sounds interesting?

Then come and join our global team as Design Quality Assurance Specialist Varian (f/m/d), to ensure the highest quality with a focus on R&D in the global Varian radiotherapy portfolio.

This position is full-time or part-time with a minimum of 30h/week.

Your tasks and responsibilities:

* You ensure compliance requirements according to applicable regulations, directives and standards, including 21CFR part 820 - QMSR, EU MDR regulation 2017/745, ISO 13485, and the company quality guidelines
* You ensure in close collaboration with design and engineering teams that all product realization processes are applied, and the product is quality-compliant
* One of your tasks is to review the design and development documentation for adequacy and ensure that they are consistent with the company wide, global processes
* You support, evaluate, and monitor the performance of required verification and validation processes and their documentation
* As Design Quality Assurance Specialist, you are involved in the design and development phase from beginning to support risk management implementing the required controls at the final production stage
* You define and ensure that statistical data is collected, and you analyze the statistical data thereafter
* You support the engineering teams with root cause analysis and corrective actions implementation
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services; Varian

Your qualifications and experience:

* You hold a degree in engineering or a related technical field
* You have many years of working experience in product development
* Ideally, you have experience in quality management including international standards and government regulations applicable to medical devices or in another regulated industry
* Experience in areas such as artificial intelligence, cloud computing, cybersecurity, radiation-emitting devices, or wireless communication is a Plus
* Ideally, you gained experience in design quality assurance in medical devices or in another regulated industry

Your attributes and skills:

* You have fluent English skills, both written and spoken. Good German skills are a Plus
* You know what is important in leadership communication and have mastered the claviature of internal communication
* Quality is close to your heart, and you like to implement our high standards together in the team when making sound risk management decisions
* In your role, your analytical skills and ability to work under pressure will help you with time-critical issues