Quality Systems Engineer

591x Varian Medical Systems, Inc.; EE. UU.; Presencial; USD 96.000 - 133.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Life Insurance

Disability Insurance

Parking/Transit

Paid Time Off

Sick Time

Descripción de la vacante

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer in Austin, TX to support manufacturing operations, supplier quality and quality systems in an ISO 13485:2016 environment. You will drive CAPA, nonconformance resolution, and continuous improvement programs across cross‑functional teams.

The role emphasizes data‑driven decision making, problem‑solving, and implementation of scalable quality practices to ensure product quality and regulatory compliance.

Formación

• Bachelor’s degree in Industrial, Mechanical, Manufacturing, Quality, or related engineering discipline, with 2+ years of experience.
• Experience supporting manufacturing operations, establishing QMS, investigations and continuous improvement.
• Working knowledge of ISO 13485:2016 or similar QMS requirements.
• Experience with structured problem‑solving and root cause analysis.
• Strong analytical skills to interpret data and drive corrective actions.

Responsabilidades

• Serve as a key quality engineering resource across quality systems and operational excellence initiatives.
• Define, implement, maintain, and improve quality system processes, procedures, work instructions, and other controlled documentation.
• Support manufacturing operations by ensuring products, processes, and quality controls meet specifications and regulatory requirements.
• Investigate and close nonconforming materials and processes, partnering with Operations and Engineering to drive resolution.
• Lead root cause investigations and CAPA activities 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 metrics.
• Support new product introductions, manufacturing readiness, process changes, and validation.
• Participate in audits, management reviews, document control, and quality systems processes for compliance.
• Collaborate with cross‑functional teams to resolve quality issues and enhance customer satisfaction.
• Apply Lean, Six Sigma, SPC, and other continuous improvement tools to reduce variation and improve yield.

Conocimientos

Quality engineering

ISO 13485

Root cause analysis

Data analysis

Lean Six Sigma

Educación

Bachelor’s degree in engineering

Herramientas

SAP

ERP systems

eQMS

Descripción del empleo

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 role will provide hands‑on support for manufacturing quality, nonconformance and CAPA processes, quality system 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.

Salary

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 affirmative 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. EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Export Control

A successful candidate must be able to work with controlled technology in accordance with US export control law. 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.