Quality Systems Engineer

Siemens Healthineers AG; Austin (TX); On-site; USD 96,000 - 133,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid time off

Job summary

Siemens Healthineers is hiring a Quality Engineer in Austin, TX to support manufacturing operations under an ISO 13485:2016 compliant environment. You will improve quality systems, lead CAPAs, and drive investigations with cross-functional teams.

The role emphasizes data-driven problem solving, SPC methods, and collaboration with Operations, Regulatory, and Supply Chain to maintain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in an engineering discipline with 2+ years in quality/manufacturing/process engineering.
• Experience supporting manufacturing operations, establishing QMS, investigations, and continuous improvement.

Responsibilities

• Define, implement, and improve quality system processes and controlled documentation to support ISO 13485:2016 compliance.
• Investigate nonconforming materials and drive timely CAPA closures with cross-functional teams.
• Lead root cause investigations and containment actions using structured problem-solving methods.
• Analyze quality data to identify trends and drive data-based improvements.
• Support new product introductions, process validation, and readiness activities.
• Participate in internal audits, management reviews, and document control processes.

Skills

ISO 13485

Root Cause Analysis

CAPA

Lean Six Sigma

Six Sigma Green Belt

CQE

Data-driven decision making

Cross-functional collaboration

Education

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

Tools

SAP

ERP systems

eQMS

SPC / Statistical tools

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 QualityEngineer to join our team in Austin, Texas. As the site's primary qualityengineering resource, you will have the opportunity to contribute to importantengineering decisions and directly support manufacturing operations, incominginspection, supplier quality, quality systems, and continuous improvementactivities within an ISO 13485:2016 -compliant manufacturing environment.Working closely with Supply Chain, Engineering, Regulatory Affairs, IT, and othercross-functional teams, the Quality Engineer will help develop, implement, andsustain scalable quality practices that ensure product quality, processeffectiveness, regulatory compliance, and operational excellence.The Quality Engineer will provide hands-on support for manufacturing quality,nonconformance and CAPA processes, quality systems administration, andoperational 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 establishpractical, sustainable quality controls that support the continued growth andsuccess 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 actionsWhat 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#LS-OS1Who 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 - $132,605Factors 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.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. 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.Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.