Quality Systems Operations Lead — CAPA & Audit

591x Varian Medical Systems, Inc.; United States; 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

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 the operation, governance, and continuous improvement of QMS processes with a focus on CAPA and nonconformance, audit and compliance.

You will collaborate with Quality, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other functions to drive QMS performance, implement risk-based quality practices, and advance digitalization of quality processes.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or related field.
• 5+ years of quality management experience; 3+ years with a Master’s degree.
• Knowledge of QMS requirements: ISO 13485:2016 and FDA QMSR.
• Experience with CAPA, nonconformance, audits, and remediation.
• Strong leadership, coaching, and cross-functional collaboration.

Responsibilities

• Lead quality systems team with clear objectives and performance expectations.
• Govern QMS processes, ownership, and escalation mechanisms.
• Oversee CAPA and nonconformance management and effectiveness verification.
• Lead internal/external audits and regulatory inspection readiness.
• Ensure QMS compliance with ISO 13485:2016, ISO 14971, and FDA QMSR, integrated risk management.

Skills

Leadership

Quality management

Analytical thinking

Problem solving

Cross-functional collaboration

Education

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

Tools

SAP

ERP systems

eQMS

MES

Microsoft Office

Dashboards

Job description

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Operations Manager to lead the operation, governance, and continuous improvement of QMS processes with a focus on CAPA and nonconformance, audit and compliance.

You will collaborate with Quality, Manufacturing, Engineering, Supply Chain, Regulatory Affairs, and other functions to drive QMS performance, implement risk-based quality practices, and advance digitalization of quality processes.