Job Detail

Together, we can beat cancer.

At Varian, we bring together the worlds’ best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions. If you want to be part of this important mission, we want to hear from you.

As a Quality Assurance Specialist at Varian, you are accountable that the design and development processes are followed, specific controls are in place and documented to ensure adequate quality at all product realization stages. You keep abreast of regulatory procedures and changes to ensure compliance throughout the complete product life cycle.

In addition, you are supporting the RA/QA team in internal and external audits. You work in close collaboration with other teams and stakeholders in Europe and overseas. Finally, due to the safety critical nature of radiation therapy, your commitment to quality is a must.

Main Responsibilities:

• Ensures compliance requirements according to 21CFR part 820, Directive 93/42/EEC, Regulation (EU) 2017/745, ISO 13485, and the company quality manual


• Ensures in close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant


• Review of the design and development documentation for adequacy and ensures that they are consistent with the company wide, global processes


• Supports, evaluates, and monitors that verification and validation processes are performed and documented


• Is involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage


• Defines statistical data collection and ensures that statistical data is analyzed thereafter


• Supports and evaluates engineering teams with the root cause analysis and corrective actions implementation
   

Qualifications:

• Degree in engineering or related technical field with comparable educational background


• Experience in design quality assurance in medical devices or in other regulated industry


• Ability to work with international standards


• Experience of working and communicating with different regulatory authorities is an additional plus that may complete your profile


• Fluence in German and English, written and verbal

In addition, you can express your ideas and research in written form. You are used to working independently, open to discussing ideas and solutions with your colleagues. You thrive in an international work environment and in cultivating your contacts with partners in Europe and overseas.

You’re just one click away from the most impactful work you will ever do and becoming part of the global team united by purpose to fight cancer. Someone, somewhere, will be glad you did.

#LI-OS1

Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.

#TogetherWeFight

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