Quality Systems Engineer: CAPA, Compliance & Analytics

Siemens Healthineers in; Palo Alto (CA); 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 and short-term disability保险

paid parking/public transportation

paid time off

paid sick and safe time

Job summary

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Engineer to support the Quality Management System (QMS) across CAPA, nonconformance, audits, and compliance in Palo Alto, California.

You will partner with Quality, Manufacturing, Engineering, Regulatory Affairs, and cross-functional teams to drive process improvements, data-driven decisions, and robust quality metrics in a regulated medical device environment.

Qualifications

• 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, or related quality function; master’s may substitute for part of experience.
• Experience with ISO 13485:2016 and/or FDA QMS requirements; CAPA and nonconformance management.
• Audits and audit readiness activities in regulated environments.

Responsibilities

• Support the implementation and continuous improvement of QMS processes.
• Lead CAPA and nonconformance management, including investigation and root cause analysis.
• Collaborate with cross-functional teams to address quality issues and implement corrective actions.
• Participate in internal and external audit readiness activities and remediation.
• Develop and maintain quality procedures, work instructions, and records.
• Establish and monitor quality performance indicators and metrics.
• Translate data analysis into actionable quality improvements.

Skills

CAPA

Nonconformance

Audit readiness

Quality data analysis

Cross-functional teamwork

Education

Bachelors in Engineering/Quality

Tools

SAP

ERP systems

eQMS

MES

MS Office

Job description

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Engineer to support the Quality Management System (QMS) across CAPA, nonconformance, audits, and compliance in Palo Alto, California.

You will partner with Quality, Manufacturing, Engineering, Regulatory Affairs, and cross-functional teams to drive process improvements, data-driven decisions, and robust quality metrics in a regulated medical device environment.