Quality Systems Leader: CAPA, Audits & 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) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

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 Operations Manager to lead CAPA, nonconformance and QMS governance across the site, ensuring compliance with ISO 13485:2016, ISO 14971:2019, and FDA QMSR while driving continuous improvement.

You will lead the Quality Systems team, set priorities, manage metrics, and partner with cross‑functional teams to embed risk‑based quality practices and digitalize processes.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or related field; 5+ years in quality management; equivalent experience.

Responsibilities

• Lead, coach, and develop the Quality Systems team at the site with clear objectives and accountability.
• Govern the Quality Management System processes, establish ownership and escalation mechanisms.
• Oversee CAPA and nonconformance management including investigation, root-cause analysis, corrective actions, and verification.
• Lead internal and external audits, readiness activities, and regulatory inspection support; remediate findings.
• Ensure compliance with ISO 13485:2016, ISO 14971:2019, FDA QMSR and related standards.
• Establish and monitor quality performance indicators and dashboards; drive actions from trends and risks.
• Drive standardization, digitalization, and continuous improvement of QMS processes across functions.
• Collaborate with R&D, Manufacturing, Supply Chain, Regulatory Affairs to integrate quality requirements.
• Provide training and coaching on QMS processes; foster a culture of quality and accountability.

Skills

CAPA management

Nonconformance management

Audit readiness

Regulatory inspections

Leadership

Cross-functional collaboration

Data analysis

Root cause analysis

Quality metrics

Risk-based thinking

Education

Bachelor’s degree in Engineering/Quality

Master’s degree (optional)

Tools

SAP

ERP systems

eQMS

MES

Microsoft Office

Dashboards

Data visualization tools

Job description

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Operations Manager to lead CAPA, nonconformance and QMS governance across the site, ensuring compliance with ISO 13485:2016, ISO 14971:2019, and FDA QMSR while driving continuous improvement.

You will lead the Quality Systems team, set priorities, manage metrics, and partner with cross‑functional teams to embed risk‑based quality practices and digitalize processes.