Quality Systems Engineer

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Quality Systems Engineer

Varian Medical Systems, a Siemens Healthineers company is seeking an onsite highly skilled and motivated Quality Systems Engineer for our Palo Alto, California location to lead the implementation and continuous improvement of quality systems. This role will primarily focus on CAPA & Non-Conformance Management, Audit & Compliance, Performance Metrics & Reporting, and driving cross-functional collaboration to optimize processes and performance.

What You will do:

• Quality Strategy Implementation & QMS Development: Implement the global quality strategy, ensuring alignment with business goals and regulatory standards. Continuously enhance the Quality Management System (QMS) and maintain quality documentation, regulations, methods, and IT tools.
• Cross-functional Collaboration: Partner with R&D, Procurement, Manufacturing, and other business units to integrate and optimize quality management practices across the organization.
• Audit & Compliance: Participate in internal audits, ensuring compliance with ISO and regulatory standards. Address non-conformities (NC) and implement corrective actions effectively.
• Process Improvement & Digital Solutions: Drive process optimization using Six Sigma, Lean, and quality tools (8D, RCA, FMEA). Lead the development of digital solutions to enhance quality performance and optimize processes.
• Training & Development: Participate in the development and deployment training programs to ensure employees are equipped to maintain quality standards and support continuous improvement.
• CAPA & Non-Conformance Management: Support the identification, documentation, and resolution of CAPA processes. Ensure non-conformities are promptly addressed and resolved with cross-functional collaboration.
• Performance Metrics & Reporting: Establish and monitor quality metrics and benchmarks. Provide regular reporting and insights to leadership to guide decision-making and continuous improvement.
• Safety Management: Develop and integrate safety standards into the quality system to maintain a safe work environment.
• Improvement Projects: Propose, lead, and take responsibility for defined improvement projects, ensuring successful execution and driving continuous improvement across quality processes.

What You will have:

• In-depth knowledge of quality management standards (e.g., ISO 13485:2016, FDA CFR 820).
• Proficient in Microsoft Office and ERP systems (e.g., Workday, SAP, MES).
• Strong problem-solving and data analysis skills, with experience using statistical tools.
• Expertise in implementing Six Sigma, Lean, and quality tools (e.g., 8D, RCA, FMEA) for continuous improvement.
• Ability to lead and coach cross-functional teams, fostering a quality-driven culture.
• Familiarity with safety management systems and integrating safety protocols into quality practices.
• Experience in CAPA processes and non-conformance management.
• Skilled in designing and delivering training programs to support quality initiatives.
• Strong ability to establish, monitor, and analyze quality metrics and performance benchmarks.
• Proven track record of leading improvement projects and driving organizational change.

Education & Experience:

• Bachelor’s degree in Engineering, Quality Management, or a related field, or equivalent experience.
• 5+ years of experience in quality management or related roles, or 3+ years with a Master’s degree.

If you’re passionate about shaping the quality culture and driving continuous improvement in an innovative environment, apply today to join our team at Varian!

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Who we are: We are a team of more than 73,000 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