Mgr, Quality Systems Operations

Job description

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 Management for Medical Devices and the application of risk-based principles within QMS processes. Strong experience with CAPA, nonconformance management, root cause investigation, corrective and preventive action, and effectiveness verification. Experience leading internal and external audits, audit readiness, regulatory inspection readiness, and remediation of audit or compliance findings. Demonstrated leadership capabilities, including the ability to coach and develop employees, establish priorities, manage resources, influence cross-functional stakeholders, and drive accountability and performance. Strong analytical and problem-solving skills, with experience using quality metrics, trends, dashboards, and operational data to identify risk and drive improvement. Demonstrated ability to lead cross-functional quality system improvement initiatives and effectively communicate quality performance, compliance risks, priorities, and recommendations to leadership. Preferred Qualifications Experience working in the medical device, healthcare, or other regulated manufacturing industry. In-depth knowledge of FDA QMSR, ISO 13485:2016, ISO 14971:2019, and applicable quality system and regulatory requirements. ISO 13485:2016 Lead Auditor certification preferred, with demonstrated audit experience in a regulated environment. Previous experience leading or managing Quality Systems professionals or a Quality Systems function. Experience with QMS governance, CAPA, nonconformance, audit remediation, compliance, and continuous improvement across multiple functions or sites. Experience applying 8D, RCA, FMEA, Lean, Six Sigma, risk-based thinking, and statistical quality methods. Experience with SAP, ERP systems, electronic Quality Management Systems (eQMS), MES, Microsoft Office, dashboards, and data visualization or reporting tools. Experience driving digitalization, automated workflows, process standardization, and organizational change within Quality Management Systems. ASQ Certified Quality Manager/Organizational Excellence (CMQ/OE), Certified Quality Engineer (CQE), Six Sigma Green Belt or Black Belt, Lean certification, or equivalent professional certification preferred. What will set you apart: Proven leadership of Quality Systems operations, balancing compliance, business priorities, operational performance, and continuous improvement. Strong experience with CAPA, nonconformance management, audit and compliance, QMS governance, and risk-based quality management. A practical, data-driven leadership approach that translates quality and compliance risks into clear priorities, ownership, accountability, and sustainable actions. Demonstrated ability to build and develop teams, influence across organizational boundaries, and drive accountability and change. The ability to translate complex quality, compliance, risk, and performance information into clear insights and recommendations for leadership. A continuous improvement mindset focused on preventing recurrence, str