Quality Systems Engineer

Siemens Healthcare; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer in Palo Alto, CA. You will support QMS processes and regulatory alignment across ISO 13485:2016 and FDA QMSR standards.

The role involves CAPA/nonconformance management, audit readiness, and collaboration with Quality, Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to strengthen compliance and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related technical discipline.
• 2+ years of experience in quality engineering, quality systems, manufacturing quality, or a related quality function (master's may substitute).
• Experience with ISO 13485:2016 and/or FDA QMS requirements and CAPA/nonconformance processes.

Responsibilities

• Support and improve Quality Management System processes in line with global quality strategies and regulatory standards.
• Assist CAPA and nonconformance management, including investigation, root cause analysis, and closure.

Skills

Quality engineering

Data analysis

Audits

Cross-functional collaboration

Problem-solving

Education

Bachelor's degree in Engineering, Quality Management, Life Sciences, or related technical discipline

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 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.

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 mul