Quality Systems Engineer

Siemens Healthineers•Greendale, WI

2d•$99,500 - $136,818

About The Position

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer to join its Quality organization in Palo Alto, California. The role supports 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 with Quality, Manufacturing, Engineering, Supply Chain, Procurement, Regulatory Affairs, and other cross-functional teams, the engineer helps keep quality processes effective, compliant, scalable, and aligned with business and regulatory requirements. The role applies quality engineering methods, data analysis, and digital solutions to identify risks, improve processes, strengthen compliance, and support continuous improvement.

Requirements

Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related technical discipline, or an equivalent combination of education and relevant experience.
At least 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 QMS 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, including the ability to interpret quality data, identify trends, assess risk, and develop effective corrective actions.
Ability to work effectively across functions and manage multiple quality activities and improvement initiatives.

Nice To Haves

Experience 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 methods, 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.
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.
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 focused on systemic opportunities and strengthening the overall QMS, beyond closing individual issues.

Responsibilities

Support implementation, maintenance, and continuous improvement of QMS 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, including preparation, evidence collection, response development, remediation, and closure of findings.
Support compliance with applicable quality and regulatory requirements, including ISO 13485:2016, FDA QMSR, and other applicable standards and regulations.
Develop, revise, and maintain quality procedures, work instructions, forms, records, and other controlled documentation.
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 to improve visibility, efficiency, and decision-making across quality processes.
Apply structured problem-solving and continuous improvement methods, including root cause analysis, 8D, FMEA, Lean, Six Sigma, and statistical methods.
Lead and support 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 development and delivery of training related to quality procedures, CAPA, nonconformance management, audit readiness, and other QMS requirements.
Support management review and other quality governance activities with performance data, trend analysis, risks, and improvement recommendations.
Promote a culture of quality, compliance, accountability, and continuous improvement.