Quality Systems Engineer

Siemens Medical Solutions USA, Inc.; United States; Presencial; USD 99.000 - 137.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Resumo da vaga

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer to join the Quality organization in Palo Alto, CA. You will support the implementation, maintenance, and continuous improvement of QMS processes, with a primary focus on CAPA and nonconformance management, audit and compliance, and quality performance metrics.

Working closely with cross-functional teams, you will help ensure quality processes remain effective, compliant, scalable, and aligned with

Qualificações

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related field, or equivalent experience.
• 2+ years in quality engineering, quality systems, or related function; master’s may substitute part of experience.
• Working knowledge of quality systems requirements in regulated environments (ISO 13485:2016/FDA QMSR).
• Experience supporting CAPA, nonconformance, root cause investigations, and corrective actions.
• Audits and audit readiness experience; strong data interpretation and risk assessment skills.
• Strong cross-functional collaboration and project management abilities.

Responsabilidades

• Support the implementation, maintenance, and continuous improvement of QMS processes aligned with regulatory standards.
• Assist CAPA and nonconformance management from initiation to closure and verification.
• Partner with cross-functional teams to investigate quality issues and implement sustainable actions.
• Contribute to internal and external audit readiness activities and remediation work.
• Ensure compliance with ISO 13485:2016, FDA QMSR, and other applicable standards.
• Develop, revise, and maintain quality procedures, forms, and records.
• Establish and analyze quality performance indicators and dashboard metrics.
• Identify trends and risks through data analysis and translate into actionable recommendations.
• Develop and enhance dashboards, reporting tools, and digital solutions for visibility.
• Apply structured problem-solving (8D, FMEA, Lean, Six Sigma) to improve system effectiveness.
• Lead or support quality system improvement projects with clear objectives and stakeholder alignment.
• Collaborate with R&D, Manufacturing, Supply Chain, Procurement, Regulatory Affairs to integrate quality requirements.
• Support training development related to CAPA, audit readiness, and QMS requirements.
• Provide management with accurate performance data and improvement recommendations.

Formação

Bachelor's degree in relevant field

Ferramentas

SAP

ERP systems

eQMS

MES

Microsoft Office

Data visualization

Descrição da vaga

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.

Responsibilities

• 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.

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 Qualifications

• 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.

Company Information

#LS-OS1

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.

Base Pay Range

$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.

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.

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Export Control

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.”