New · posted Nov 8
Siemens Healthineers · Medical Devices
Quality Systems Engineer
- Palo Alto, CA
- On-site
- Full-time
- Associate & Specialist
The role
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 Systems Engineer to join our Quality organization in Palo Alto, California. In this role, you will support the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes, with a primary focus on CAPA and nonconformance management, audit and compliance, quality performance metrics, and continuous improvement.
Working closely with Quality, Manufacturing, Engineering, Supply Chain, Procurement, Regulatory Affairs, and other cross-functional teams, the Quality Systems Engineer will help ensure quality processes remain effective, compliant, scalable, and aligned with business and regulatory requirements.
The role will also leverage quality engineering methodologies, data analysis, and digital solutions to identify risks, improve processes, strengthen compliance, and support a culture of continuous improvement.
In this role, you will mainly be responsible for the following:
- Support the implementation, maintenance, and continuous improvement of Quality Management System processes in alignment with global quality strategies, business requirements, and applicable regulatory standards.
- Support CAPA and nonconformance management, including initiation, investigation, root cause analysis, action planning, implementation, effectiveness verification, and timely closure.
- Partner with cross-functional teams to investigate quality issues, identify systemic risks, and implement sustainable corrective and preventive actions.
- Participate in internal and external audit readiness activities, including audit preparation, evidence collection, response development, remediation activities, and closure of audit findings.
- Support compliance with applicable quality and regulatory requirements, including ISO 13485:2016, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.
- Develop, revise, and maintain quality procedures, work instructions, forms, records, and other controlled documentation supporting Quality Management System processes.
- Establish, monitor, analyze, and report quality performance indicators and operational metrics, including CAPA, nonconformance, audit, compliance, and process performance measures.
- Identify trends, recurring issues, and emerging risks through data analysis and translate findings into actionable recommendations for Quality and business leadership.
- Develop and enhance dashboards, reporting tools, and digital solutions that improve visibility, efficiency, and decision-making across quality processes.
- Apply structured problem-solving and continuous improvement methodologies, including root cause analysis, 8D, FMEA, Lean, Six Sigma, and statistical methods, to improve quality system effectiveness.
- Lead and support defined quality system improvement projects from planning through implementation, ensuring clear objectives, stakeholder alignment, and sustainable results.
- Partner with R&D, Manufacturing, Supply Chain, Procurement, Regulatory Affairs, and other functions to integrate quality requirements into business processes and strengthen cross-functional execution.
- Support the development and delivery of training related to quality procedures, CAPA, nonconformance management, audit readiness, and other Quality Management System requirements.
- Support management review and other quality governance activities by providing accurate performance data, trend analysis, risks, and improvement recommendations.
- Promote a culture of quality, compliance, accountability, and continuous improvement across the organization.
What you need
Minimum Requirements
- Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related technical discipline, or equivalent combination of education and relevant experience.
- 2+ years of experience in quality engineering, quality systems, manufacturing quality, or a related quality function. A master's degree may substitute for a portion of the required experience.
- Working knowledge of Quality Management System requirements in a regulated environment, including ISO 13485:2016 and/or FDA quality system requirements.
- Experience supporting CAPA, nonconformance management, root cause investigations, and corrective action processes.
- Experience participating in or supporting internal or external audits and audit readiness activities.
- Strong analytical and problem-solving skills with the ability to interpret quality data, identify trends, assess risk, and develop effective corrective actions.
- Demonstrated ability to work effectively across functions and manage multiple quality activities and improvement initiatives.
Preferred Qualificationsnice to have
- Experience working in the medical device, healthcare, or other regulated manufacturing industry.
- Working knowledge of FDA QMSR, ISO 13485:2016, risk management principles, and applicable quality system requirements.
- Experience applying structured problem-solving and continuous improvement methodologies, including 8D, RCA, FMEA, Lean, Six Sigma, and statistical quality methods.
- Experience developing and monitoring quality metrics, dashboards, management reporting, and performance indicators.
- Experience with SAP, ERP systems, electronic Quality Management Systems (eQMS), MES, Microsoft Office, and data visualization or reporting tools.
- Experience developing or improving digital solutions, workflows, or analytics used to support quality processes.
- Experience developing and delivering quality system training.
- ASQ Certified Quality Engineer (CQE), Six Sigma Green Belt, Lean certification, or equivalent professional certification preferred.
What will set you apart:
- Strong experience with CAPA, nonconformance management, and quality system improvement in a regulated environment.
- A practical, data-driven approach to identifying quality issues, determining root cause, and implementing sustainable solutions.
- The ability to translate quality and compliance data into clear insights, priorities, and actions for leadership.
- Demonstrated success leading cross-functional improvement initiatives and influencing stakeholders without direct authority.
- An improvement mindset that looks beyond closing individual issues to identifying systemic opportunities and strengthening the overall Quality Management System.
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:
$99,500 - $136,818
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.
EEO is the Law: Applicants and employees are protected under Federal law from discrimination. 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.”
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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.
Pay and benefits
$99,500 – $136,818 a year
Employer providedMedical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life and disability insurance
Paid time off
Where you'll work
Palo Alto, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Palo Alto, CAEqual opportunity, accessibility and legal noticesSiemens Healthineers's statements, word for word
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.
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 [email protected]. 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.
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.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 28% above the US median for Quality Systems & Document Control roles at this level.
This roleEmployer provided
Associate & Specialist roles in California5 roles publishing pay
Associate & Specialist roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $99,500 | — | $136,818 |
| California (middle half) | $92,000 | $93,500 | $118,500 |
| All US (middle half) | $78,375 | $92,000 | $102,625 |
This role: Siemens Healthineers's own published range. Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 89 open Quality Systems & Document Control roles on Regulatory Jobs, with the titles they carry most. Not Siemens Healthineers's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 53 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk20
- GMP and compliance11
- Collaboration and leadership11
- Investigations and CAPA9
- Lab testing and methods4
- Documentation and SOPs3
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health dataNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDAMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program shared by five regulators
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR Part 807(official source, opens in a new tab)Establishment registration, device listing and premarket notification
Company hiring pulse
Siemens Healthineers on Regulatory Jobs
- 26
- Open roles
- 26
- Distinct roles
- 10
- Locations
By discipline
- Quality21 81%
- Regulatory5 19%
By level
- Senior & Principal12 46%
- Associate & Specialist10 38%
- Manager2 8%
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Quality Systems Engineer at Siemens Healthineers
Open until filled. $100K–$137K a year, employer provided.