Together, we can beat cancer.
At Varian, a Siemens Healthineers Company, we bring together the world’s 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.
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
If you want to be part of this important mission, we want to hear from you.
As a Design 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.
You are communicative, focused and analytical. 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.

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 the required verification and validation processes are performed and documented.
• Involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage.
• Defines and ensures that statistical data is collection and analyses of the statistical data thereafter.
• Supports and evaluates engineering teams with the root cause analysis and corrective actions implementation.

Requirements:

• Degree in engineering or related technical field with comparable educational background
• Experience in international standards and government regulations applicable to medical devices, preferably in artificial intelligence, cloud computing, radiation emitting devices, or wireless communication
• Experience in design quality assurance in medical devices or in other regulated industry
• Ability to work with international standards and regulations applicable to medical devices
• Experience of working and communicating with different regulatory authorities and corresponding relationships is an additional plus that may complete your profile
• Fluency in English, written and verbal. German language skills are a plus.

LI-OS1

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.
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

About Us
Together, we can beat cancer.
Imagine a world without fear of cancer. We do, every day. Varian Medical Systems is the world’s leading manufacturer of medical devices and software for treating and managing cancer. For more than 70 years, we have developed, built, and delivered innovative cancer care technologies and solutions for our clinical partners around the globe to help them treat millions of patients each year.
Taking an Intelligent Cancer Care approach, we are harnessing advanced technologies like artificial intelligence, machine learning, and data analytics to advance cancer treatment and expand access to care to help patients become survivors.
When you join Varian, you become part of a global network of innovative and inspired minds working together across the globe. We keep the patient and our clinical partners at the center of our thinking as we power new victories in cancer care. Because for cancer patients everywhere, their fight is our fight.

• 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 the required verification and validation processes are performed and documented.
• Involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage.
• Defines and ensures that statistical data is collection and analyses of the statistical data thereafter.
• Supports and evaluates engineering teams with the root cause analysis and corrective actions implementation