Design Quality Assurance Specialist - Onsite

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Varian Medical Systems, a Siemens Healthineers company is hiring for a Design Quality Assurance Specialist in one of the 2 following locations (Shoreview, MN or Austin, TX). In this role you will be accountable for the design and development processes, ensuring specific controls are in place and documented to meet adequate quality at all product realization stages.

You will keep abreast of regulatory procedures and changes to ensure compliance throughout the complete product life cycle.

In addition, you will support the QT team in internal and external audits and work in close collaboration with other teams and stakeholders in North America and overseas.

Finally, due to the safety critical nature of medical devices, your commitment to quality is a must.

The successful applicant is 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 North America and overseas.

• Ensure compliance requirements are met according to applicable regulations, directives and standards, including 21
  
  CFR part 820 - QMSR, EU MDR regulation 2017/745, ISO 13485, and the company quality manual.
• Ensure close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant.
• Review the design and development documentation for adequacy and ensure that they are consistent with the company wide, global processes.
• Support, evaluate, and monitor that the required verification and validation processes are performed and documented.
• Stay involved in design and development phase from beginning to support risk management and to implement the required controls at the final production stage.
• Define and ensure that statistical data is collected and analyzed.
• Support and evaluate engineering teams with root cause analysis and corrective actions implementation.

• B.S. degree in a related field (Mechanical Engineering, Electrical Engineering, Chemical Engineering, or Chemistry) and 7+ years of related experience in medical device (preferred) or pharmaceutical industry OR M.S. Degree with 4+ years of related experience
• Experience in product development or in design quality assurance in medical devices or in other regulated industry
• Ability to work with international standards and regulations applicable to medical devices
• Preferred – ASQ Certified Quality Engineer or Certified Reliability Engineer
• Knowledgeable in advanced statistics, process control, design of experiments, etc
• Understanding of chemical manufacturing and basic laboratory skills
• Previous work experience in controlled environments and clean rooms

• Understanding of chemical manufacturing and basic laboratory skills, preferred
• Experience with polymer chemistry, preferred

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision‑making and treatment pathways.

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united…