Mgr, Quality Systems Operations

Siemens Healthcare; United States; In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Varian Medical Systems, a Siemens Healthineers company, seeks a Quality Systems Operations Manager to lead QMS governance, CAPA, and compliance. You will drive continuous improvement across ISO 13485:2016, ISO 14971:2019, and FDA QMSR, partnering with Quality, Manufacturing, Engineering, and Regulatory Affairs.

You will develop the Quality Systems team, establish metrics, and ensure timely inspection responses, audits, and risk-based decision making across the organization.

Competenze

• Bachelor's degree in Engineering, Quality Management, or related field, or equivalent experience.
• 5+ years of experience in quality management or related roles, or 3+ years with a Master's degree.
• Demonstrated knowledge and experience with QMS requirements in a regulated environment, including ISO 13485:2016 and FDA quality system requirements.
• Working knowledge of ISO 14971:2019 Risk Management

Mansioni

• Lead, coach, and develop the Quality Systems team at the site, establishing clear objectives, priorities, responsibilities, and performance expectations while ensuring appropriate capabilities and resources are in place.
• Lead the governance, maintenance, and continuous improvement of assigned Quality Management System processes, establishing clear process ownership, accountability, performance expectations, and escalation mechanisms.
• Provide operational leadership and oversight for CAPA and nonconformance management, ensuring effective investigation, root cause analysis, corrective and preventive action, effectiveness verification, timely closure, and escalation of significant or systemic issues.
• Lead internal and external audit readiness and regulatory inspection support, ensuring effective preparation, organizational alignment, response development, remediation, and timely closure of findings.
• Ensure assigned QMS processes comply with applicable requirements, including ISO 13485:2016, ISO 14971:2019 Risk Management for Medical Devices, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.
• Ensure appropriate risk-based principles and medical device risk management requirements are integrated into QMS processes, partnering with functions responsible for product risk management where applicable.
• Establish and monitor quality performance indicators and operational metrics across CAPA, nonconformance, audit, compliance, and other QMS processes; identify systemic trends and risks and drive appropriate actions and escalation.
• Provide leadership with clear visibility into QMS health, performance compliance risks, and improvement priorities through effective management reporting, dashboards, and quality governance forums.
• Drive standardization, simplification, digitalization, and continuous improvement of quality system processes, prioritizing initiatives that improve compliance, effectiveness, efficiency, and organizational performance.
• Promote the effective application of root cause analysis, 8D, FMEA, Lean, Six Sigma, risk-based thinking, and statistical methods across Quality Systems activities.
• Partner with R&D, Manufacturing, Supply Chain, Procurement, Regulatory Affairs, and other functions to integrate quality requirements into business processes, resolve cross-functional issues, and strengthen accountability for QMS execution.
• Establish training and competency priorities for assigned QMS processes and ensure appropriate training, coaching, and guidance are available to Quality professionals, process owners, and cross-functional stakeholders.
• Promote a culture of quality, compliance, accountability, collaboration, and continuous improvement across the organization.

Conoscenze

Quality management

Regulatory compliance

Risk management

Leadership

Audit readiness

Cross-functional collaboration

CAPA & nonconformance

Formazione

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

Descrizione del lavoro

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Implements overarching quality mission and strategy, and ensures implementation of an open quality culture, for all assigned quality areas. Acts as quality consultant for own organization. Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Operations Manager to join our Quality organization. In this role, you will lead the effective operation, governance, and continuous improvement of Quality Management System (QMS) processes, with a primary focus on CAPA and nonconformance management, audit and compliance, quality performance management, risk-based quality practices, and continuous improvement.

Working closely with Quality, Manufacturing, Engineering, Supply Chain, Procurement, Regulatory Affairs, and other cross-functional teams, you will lead the Quality Systems team, establish priorities and accountability, and ensure QMS processes remain effective, compliant, scalable, and aligned with business and regulatory requirements.

In this role, you will mainly be responsible for the following:

• Lead, coach, and develop the Quality Systems team at the site, establishing clear objectives, priorities, responsibilities, and performance expectations while ensuring appropriate capabilities and resources are in place.
• Lead the governance, maintenance, and continuous improvement of assigned Quality Management System processes, establishing clear process ownership, accountability, performance expectations, and escalation mechanisms.
• Provide operational leadership and oversight for CAPA and nonconformance management, ensuring effective investigation, root cause analysis, corrective and preventive action, effectiveness verification, timely closure, and escalation of significant or systemic issues.
• Lead internal and external audit readiness and regulatory inspection support, ensuring effective preparation, organizational alignment, response development, remediation, and timely closure of findings.
• Ensure assigned QMS processes comply with applicable requirements, including ISO 13485:2016, ISO 14971:2019 Risk Management for Medical Devices, FDA Quality Management System Regulation (QMSR), and other applicable standards and regulations.
• Ensure appropriate risk-based principles and medical device risk management requirements are integrated into QMS processes, partnering with functions responsible for product risk management where applicable.
• Establish and monitor quality performance indicators and operational metrics across CAPA, nonconformance, audit, compliance, and other QMS processes; identify systemic trends and risks and drive appropriate actions and escalation.
• Provide leadership with clear visibility into QMS health, performance compliance risks, and improvement priorities through effective management reporting, dashboards, and quality governance forums.
• Drive standardization, simplification, digitalization, and continuous improvement of quality system processes, prioritizing initiatives that improve compliance, effectiveness, efficiency, and organizational performance.
• Promote the effective application of root cause analysis, 8D, FMEA, Lean, Six Sigma, risk-based thinking, and statistical methods across Quality Systems activities.
• Partner with R&D, Manufacturing, Supply Chain, Procurement, Regulatory Affairs, and other functions to integrate quality requirements into business processes, resolve cross-functional issues, and strengthen accountability for QMS execution.
• Establish training and competency priorities for assigned QMS processes and ensure appropriate training, coaching, and guidance are available to Quality professionals, process owners, and cross-functional stakeholders.
• Promote a culture of quality, compliance, accountability, collaboration, and continuous improvement across the organization.

Minimum Requirements

• 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.
• Demonstrated knowledge and experience with Quality Management System requirements in a regulated environment, including ISO 13485:2016 and FDA quality system requirements.
• Working knowledge of ISO 14971:2019 Risk Managem