Design Quality Assurance Specialist - Onsite

Siemens Healthineers

12d•Onsite

About The Position

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. 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.

Requirements

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
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 cleanrooms

Nice To Haves

ASQ Certified Quality Engineer or Certified Reliability Engineer
Understanding of chemical manufacturing and basic laboratory skills
Experience with polymer chemistry

Responsibilities

Ensure compliance requirements are met according to applicable regulations, directives and standards, including 21CFR 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.