Quality Systems Engineer

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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, effi...