Sr. Design Quality Assurance Specialist (onsite)

onehealthineers; Austin (TX); On-site; AUD 160,000 - 220,000; Full time

Benefits offered by this job

medical insurance

dental insurance

vision insurance

401(k) retirement plan

Job summary

Varian Medical Systems, a Siemens Healthineers company, is hiring a Design Quality Assurance Specialist in Austin, TX. You will ensure compliance with QMS standards and collaborate across design and engineering to maintain product realization quality.

You will analyze documentation, support audits, and drive risk management throughout development and production in a global context. Excellent communication and analytical skills are essential.

Qualifications

• B.S. in related field (Mechanical/Electrical/Chemical Eng or Chemistry) with 7+ years of medical device or pharma experience OR M.S. with 4+ years of related experience.
• Experience in product development or design quality assurance in medical devices or other regulated industry.
• Ability to work with international standards and regulations for medical devices.
• ASQ Certified Quality Engineer or Certified Reliability Engineer preferred.
• Knowledge of advanced statistics, process control, and design of experiments.
• Experience with controlled environments and cleanrooms.

Responsibilities

• Ensure compliance with 21 CFR Part 820, EU MDR 2017/745, ISO 13485, and company quality manual.
• Collaborate with design and engineering to ensure product realization processes are applied and compliant.
• Review design and development documentation for adequacy and alignment with global processes.
• Support and monitor verification and validation activities and documentation.
• Involve early in design to support risk management and control implementation at production.
• Define and analyze statistical data and support root-cause analysis and corrective actions.

Skills

Communicative

Analytical

Written communication

Independent worker

International collaboration

Education

B.S. in related field (Mechanical Engineering, Electrical Engineering, Chemical Engineering, or Chemistry)

M.S. degree with 4+ years of related experience

ASQ Certified Quality Engineer

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 the following location, 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