Sr. Design Quality Assurance Specialist

Regulatory Jobs; Austin (TX); On-site; USD 112,000 - 155,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers in Austin, TX is seeking a Design Quality Assurance Specialist to oversee design and development, ensuring compliance with 21 CFR 820, EU MDR, and ISO 13485. You will collaborate with design and engineering teams to apply product realization processes and maintain product quality throughout the lifecycle.

You will support audits, work with North America and overseas, and contribute to risk management, data analysis, and CAPA activities in a global, fast-paced environment.

Qualifications

• B.S. degree in engineering or related field with 7+ years of experience in medical devices or pharmaceutical industry, or M.S. with 4+ years of related experience.
• Experience in product development or design quality assurance in medical devices or regulated industry.
• Ability to work with international standards and regulations applicable to medical devices.
• ASQ Certified Quality Engineer or Certified Reliability Engineer (preferred)

Responsibilities

• Ensure compliance requirements are met according to applicable regulations and standards (21CFR 820, EU MDR 2017/745, ISO 13485).
• Collaborate with design and engineering teams to apply product realization processes and ensure compliance.
• Review design and development documentation for adequacy and alignment with global processes.
• Support verification and validation activities and document results.
• Engage in design and development to support risk management and final production controls.
• Define and analyze statistical data.
• Support root cause analysis and corrective actions implementation.

Skills

Regulatory awareness

Quality mindset

Analytical thinking

Communication

Education

B.S. in Engineering or related field +7+ years OR M.S. +4+ years

Tools

ASQ Certification

Regulatory knowledge

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.

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
• 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 cleanrooms

What will set You apart:

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

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.

To find out more about Siemens Healthineers businesses, please visit our company page here.

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.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan.
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

Siemens Healthineers is an Equal Opportunity and Affidantive Action Employer encouraging diversity in the workplace. 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.

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

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.

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: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.