Sr. Design Quality Assurance Specialist (onsite)

591x Varian Medical Systems, Inc.

United States

On-site

USD 112,000 - 155,000

Full time

6 days ago

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Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Parking/Transit assistance

Paid time off

Paid sick time

Job summary

Varian Medical Systems, in Austin, TX, seeks a Design Quality Assurance Specialist to oversee design and development quality controls across the product lifecycle. You will ensure regulatory compliance and collaborate with cross-functional teams to maintain high standards in medical devices.

You will support verifications, validations, and risk management activities, working with international partners to ensure global adherence to standards and processes.

Qualifications

B.S. degree with 7+ years in medical devices or pharmaceutical QC.
M.S. degree with 4+ years of related experience is also acceptable.

Responsibilities

Ensure compliance with 21 CFR Part 820, EU MDR 2017/745, ISO 13485 and internal QA standards.
Collaborate with design and engineering to ensure product realization processes meet requirements.
Review design and development documentation for adequacy and alignment with global processes.
Support verification and validation activities and document outcomes.
Involve in design phases to support risk management and production controls.
Define and analyze statistical data used in product quality decisions.
Assist engineering with root cause analysis and corrective actions.

Skills

Quality assurance

Regulatory knowledge

Cross-functional collaboration

Root cause analysis

Statistical analysis

Education

Bachelor's degree in related field

Master's degree in related field

Job description

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.

Design Quality Assurance Specialist – Austin, TX

Varian Medical Systems, a Siemens Healthineers company is hiring for a Design Quality Assurance Specialist in 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 lifecycle. 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.

What You will do

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.

What You will have

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
ASQ Certified Quality Engineer or Certified Reliability Engineer (preferred)
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

What will set You apart

Understanding of chemical manufacturing and basic laboratory skills, preferred
Experience with polymer chemistry, preferred
#LS-OS1

Who we are

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.

How we work

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 by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Equal Employment Opportunity Statement

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Aff… All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Reasonable Accommodations

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at peopleconnectvendorsnam.func@siemens-healthineers.com. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice

California residents have the right to receive additional notices about their personal information.

Export Control

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

Data Privacy

Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

Additional Information

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways. Our culture: 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.

Salary and Benefits

The base pay range for this position is: $112,420 - $154,572. Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.