Quality Systems Engineer

Siemens Healthineers AG; Schönhausen; On-site; EUR 86,000 - 119,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Engineer to join our Austin, TX site. You will be the site’s primary quality engineering resource, supporting manufacturing operations, supplier quality, quality systems, and continuous improvement within an ISO 13485:2016 environment.

You will work across Operations, Engineering, Supply Chain, Product Quality, and Quality Systems to drive corrective and preventive actions, risk assessment, and data‑driven improvements,

Qualifications

• Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or related engineering with 2+ years in quality/manufacturing/process engineering.
• Experience establishing Quality Management Systems (QMS), quality investigations, and continuous improvement initiatives.
• Working knowledge of ISO 13485:2016 or similar quality management system requirements.
• Experience using structured problem‑solving and root cause analysis methodologies to investigate and resolve quality issues.
• Strong analytical skills with the ability to interpret data, identify trends, and drive effective corrective actions.

Responsibilities

• Serve as a key quality engineering resource across quality systems and operational excellence initiatives.
• Define, implement, maintain, and improve quality system processes, procedures, and controlled documents to support ISO 13485:2016 compliance.
• Support manufacturing operations by ensuring products, processes, and quality controls meet specifications and regulatory requirements.
• Investigate and close nonconforming materials and CAPA actions with cross‑functional partners.
• Lead root cause investigations and preventive actions using structured problem solving methodologies.
• Analyze quality system data to identify trends and drive data‑based improvements.
• Establish and report key quality performance indicators and supplier performance metrics.
• Support new product introductions, process changes, and production readiness activities.
• Participate in internal audits, management reviews, and document control processes to ensure site compliance.

Skills

Quality engineering

CAPA

QMS

ISO 13485

Data analysis

Education

Bachelor's degree in Industrial/Mechanical/Manufacturing/Quality engineering

Tools

SAP

ERP systems

eQMS

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 seeking a Quality
Engineer to join our team in Austin, Texas. As the site’s primary quality
engineering resource, you will have the opportunity to contribute to important
engineering decisions and directly support manufacturing operations, incoming
inspection, supplier quality, quality systems, and continuous improvement
activities within an ISO 13485:2016 -compliant manufacturing environment.
Working closely with Supply Chain, Engineering, Regulatory Affairs, IT, and other
cross-functional teams, the Quality Engineer will help develop, implement, and
sustain scalable quality practices that ensure product quality, process
effectiveness, regulatory compliance, and operational excellence.
The Quality Engineer will provide hands‑on support for manufacturing quality,
nonconformance and CAPA processes, quality systems administration, and
operational improvement initiatives. Leveraging quality engineering tools, data‑driven decision‑making, and structured problem‑solving methodologies, this role will identify risks, drive corrective and preventive actions, and establish
practical, sustainable quality controls that support the continued growth and
success of the Austin, TX operation.

What You will do:

• Serve as a key quality engineering resource across quality systems, and operational excellence initiatives.
• Define, implement, maintain, and continuously improve quality system processes, procedures, work instructions, and other related controlled documentation to support Austin operations and ISO 13485:2016 compliance.
• Support manufacturing operations by ensuring products, processes, and quality controls meet established specifications, regulatory requirements, and customer expectations.
• Investigate, document, and support the timely closure of nonconforming materials, components, processes, and finished goods while partnering with Operations, Engineering, Supply Chain, and other stakeholders to drive timely resolution.
• Lead and support root cause investigations, containment actions, corrective and preventive actions (CAPA), and recurrence prevention efforts using structured problem‑solving methodologies.
• Analyze quality system data to identify trends, mitigate risks, and drive data‑based improvements.
• Establish, monitor, and report key quality performance indicators, including yield, defect trends, supplier performance, inspection effectiveness, calibration compliance, and issue closure metrics.
• Support new product introductions, manufacturing readiness activities, process changes, equipment qualification, risk assessments, process validation, and production builds as needed.
• Participate as needed in internal audits, management reviews, document control activities, and other quality system processes to ensure site compliance and audit readiness.
• Partner closely with Operations, Manufacturing Engineering, Supply Chain, Product Quality, Supplier Quality, Quality Systems, and site leadership to resolve quality issues, strengthen process controls, and enhance customer satisfaction.
• Apply Lean, Six Sigma, statistical methods, and continuous improvement tools to reduce variation, improve yield, lower the cost of poor quality, and drive operational excellence.

What You will have:

• Bachelor’s degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline, with 2+ years of experience in a quality, manufacturing, or process engineering role.
• Experience supporting manufacturing operations, establishing Quality Management Systems (QMS), quality investigations, and continuous improvement initiatives.
• Working knowledge of ISO 13485:2016 or similar quality management system requirements.
• Experience using structured problem‑solving and root cause analysis methodologies to investigate and resolve quality issues.
• Strong analytical skills with the ability to interpret data, identify trends, and drive effective corrective actions

What will set You apart:

• Experience in an ISO 13485:2016 and/or regulated manufacturing environment.
• Experience in establishing a Quality Management System (QMS), supporting investigations, audits, and other elements of quality systems activities.
• Working knowledge of calibration and metrology systems, equipment qualification, process validation, and statistical quality methods.
• Familiarity with continuous improvement and problem‑solving methodologies, including Lean Manufacturing, Six Sigma, SPC, FMEA, and 8D.
• Experience with SAP, ERP systems, electronic quality management systems (eQMS), and quality reporting or analytics tools.
• ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent professional certification preferred.
• Broad quality engineering experience spanning manufacturing, incoming inspection, supplier quality, and quality systems.
• A practical, hands‑on approach to improving processes, solving problems, and supporting manufacturing operations.
• Demonstrated success building scalable quality processes, controls, and systems in a dynamic manufacturing environment.
• Strong collaboration and influencing skills, with a track record of driving sustainable improvements in quality, compliance, and business performance

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:

$96,440 - $132,605

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.

Benefits:

• 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.

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. 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.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre‑employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. 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. To learn more, click here.

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. 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.