Quality Systems Engineer: CAPA & Compliance Innovator

Siemens Healthcare; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer in Palo Alto, CA. You will support QMS processes and regulatory alignment across ISO 13485:2016 and FDA QMSR standards.

The role involves CAPA/nonconformance management, audit readiness, and collaboration with Quality, Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to strengthen compliance and continuous improvement.

Qualifications

• Bachelor's degree in Engineering, Quality Management, Life Sciences, or a related technical discipline.
• 2+ years of experience in quality engineering, quality systems, manufacturing quality, or a related quality function (master's may substitute).
• Experience with ISO 13485:2016 and/or FDA QMS requirements and CAPA/nonconformance processes.

Responsibilities

• Support and improve Quality Management System processes in line with global quality strategies and regulatory standards.
• Assist CAPA and nonconformance management, including investigation, root cause analysis, and closure.

Skills

Quality engineering

Data analysis

Audits

Cross-functional collaboration

Problem-solving

Education

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

Job description

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Engineer in Palo Alto, CA. You will support QMS processes and regulatory alignment across ISO 13485:2016 and FDA QMSR standards.

The role involves CAPA/nonconformance management, audit readiness, and collaboration with Quality, Manufacturing, Engineering, Regulatory Affairs, and Supply Chain to strengthen compliance and continuous improvement.