QMS Operations Lead (CAPA & Compliance)

Siemens Healthineers AG; Palo Alto (CA); On-site; USD 134,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Life Insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Operations Manager to lead the operation, governance, and continuous improvement of QMS with a focus on CAPA, nonconformance management, audits, and regulatory compliance.

You will work with Quality, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other cross-functional teams to drive priorities, accountability, and performance, ensuring QMS processes remain effective, compliant, scalable, and

Qualifications

• Bachelor’s degree or equivalent in a relevant field.
• 5+ years in quality management; master’s 3+ years acceptable.
• Experience with regulated QMS requirements (ISO 13485, FDA QMSR).
• Strong CAPA, nonconformance and audit capabilities.
• Proven leadership and cross-functional collaboration.

Responsibilities

• Lead the Quality Systems team at the site with clear objectives and performance expectations.
• Govern and continuously improve QMS processes, CAPA, and nonconformance management.
• Oversee CAPA investigations, root cause analysis, corrective actions, and verification.
• Lead internal/external audits and regulatory inspection readiness and remediation.
• Ensure compliance with ISO 13485:2016, ISO 14971:2019, and FDA QMSR; drive risk-based thinking.
• Drive quality performance metrics, dashboards, and governance forums.
• Collaborate with R&D, Manufacturing, Supply Chain, Regulatory Affairs and others.

Skills

CAPA management

Nonconformance handling

Audit readiness

Quality metrics

Cross-functional leadership

Education

Bachelor's degree in Engineering, Quality Management, or related field

Tools

ISO 13485:2016

ISO 14971:2019

FDA QMSR

eQMS

SAP / ERP systems

Job description

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Operations Manager to lead the operation, governance, and continuous improvement of QMS with a focus on CAPA, nonconformance management, audits, and regulatory compliance.

You will work with Quality, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other cross-functional teams to drive priorities, accountability, and performance, ensuring QMS processes remain effective, compliant, scalable, and