Quality Systems Engineer: CAPA & Audit Focus

Siemens Healthineers AG; Greendale (WI); On-site; USD 100,000 - 137,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Paid time off

Job summary

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Engineer to join our Quality organization in Palo Alto, CA. You will support QMS processes with a primary focus on CAPA and nonconformance management, audits, and regulatory compliance.

You will partner with Quality, Manufacturing, Engineering, and Regulatory Affairs to ensure quality processes remain effective, compliant, and scalable.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, Life Sciences, or related discipline.
• 2+ years of experience in quality engineering, quality systems, or related quality function.
• Working knowledge of QMS requirements in regulated environments (ISO 13485:2016 / FDA QMSR).
• Experience supporting CAPA, nonconformance management, and root cause investigations.
• Experience participating in audits and audit readiness activities.
• Strong analytical and problem-solving skills with data interpretation.
• Ability to work across functions and manage multiple quality activities.

Responsibilities

• Support the implementation and continuous improvement of QMS processes.
• Lead CAPA and nonconformance investigations and closure.
• Collaborate with cross-functional teams to address quality issues.
• Prepare for internal and external audits and manage remediation.
• Develop and maintain quality procedures and documentation.
• Develop dashboards and metrics for quality performance.
• Apply 8D, FMEA, Lean, Six Sigma and other methods.
• Lead quality system improvement projects from planning through implementation.

Skills

CAPA handling

Nonconformance management

Audit readiness

Quality metrics

Data analysis

Cross-functional collaboration

Problem solving

Education

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

Master’s degree may substitute for required experience

Tools

eQMS software

SAP

MS Office

Data visualization tools

Job description

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Engineer to join our Quality organization in Palo Alto, CA. You will support QMS processes with a primary focus on CAPA and nonconformance management, audits, and regulatory compliance.

You will partner with Quality, Manufacturing, Engineering, and Regulatory Affairs to ensure quality processes remain effective, compliant, and scalable.