Quality Systems Operations Leader

Regulatory Jobs; Palo Alto (CA); Sur place; USD 134 000 - 184 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Résumé du poste

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Operations Manager to govern QMS efficiency and regulatory alignment at the Palo Alto site. You will lead CAPA, audits, risk management, and cross-functional collaboration to drive quality performance and continuous improvement.

You will mentor the Quality Systems team, establish KPIs, and ensure compliance with ISO 13485, FDA QMSR, and ISO 14971, enabling scalable quality processes across manufacturing and

Qualifications

• Bachelor’s degree in Engineering, Quality Management, or a related field, or equivalent experience.
• 5+ years of experience in quality management or related roles, or 3+ years with a Master’s degree.
• Knowledge of QMS requirements in regulated environments including ISO 13485:2016 and FDA QMSR.
• Experience with ISO 14971:2019 Risk Management and risk-based quality approaches.
• Strong CAPA, nonconformance management, investigation, corrective and preventive action, and effectiveness verification.
• Experience leading internal/external audits, audit readiness, and regulatory inspections.
• Demonstrated leadership, coaching, prioritization, resource management, and cross-functional influence.
• Strong analytical skills, using metrics, dashboards, and data to drive improvement.
• Ability to communicate quality performance, risks, and priorities to leadership.

Responsabilités

• Lead the Quality Systems team at the site with clear objectives, priorities, responsibilities, and performance expectations.
• Govern and continuously improve assigned QMS processes with defined ownership and escalation.
• Provide operational leadership for CAPA and nonconformance management, including investigations and effectiveness verification.
• Lead internal and external audits and support regulatory inspections, including remediation of findings.
• Ensure QMS processes comply with ISO 13485:2016, ISO 14971:2019, FDA QMSR, and other applicable standards.
• Incorporate risk-based principles into QMS processes and partner with product risk management teams.
• Establish and monitor quality performance indicators and metrics across CAPA, nonconformance, audit, and compliance.
• Provide management with visibility into QMS health through dashboards and governance forums.
• Drive standardization, digitalization, and continuous improvement of quality system processes.
• Promote use of 8D, FMEA, Lean, Six Sigma, and statistical methods across QMS activities.
• Partner with R&D, Manufacturing, Supply Chain, Regulatory Affairs to integrate quality requirements into business processes.
• Establish training and competency priorities for QMS processes and provide coaching to quality professionals and stakeholders.
• Foster a culture of quality, compliance, accountability, collaboration, and continuous improvement.

Connaissances

QMS knowledge

CAPA & nonconformance

Audit readiness

Leadership

Risk management

Cross-functional collaboration

Formation

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

Outils

SAP

ERP systems

eQMS

MES

Microsoft Office

Dashboards

Description du poste

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Operations Manager to govern QMS efficiency and regulatory alignment at the Palo Alto site. You will lead CAPA, audits, risk management, and cross-functional collaboration to drive quality performance and continuous improvement.

You will mentor the Quality Systems team, establish KPIs, and ensure compliance with ISO 13485, FDA QMSR, and ISO 14971, enabling scalable quality processes across manufacturing and