Mgr, Quality Systems Operations

Siemens Healthineers•Greendale, WI

2d•$133,740 - $183,887

About The Position

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Systems Operations Manager to lead the effective operation, governance, and continuous improvement of Quality Management System (QMS) processes. The role focuses primarily on CAPA and nonconformance management, audit and compliance, quality performance management, risk-based quality practices, and continuous improvement. The manager leads the site Quality Systems team and works with Quality, Manufacturing, Engineering, Supply Chain, Procurement, Regulatory Affairs, and other functions to ensure QMS processes remain effective, compliant, scalable, and aligned with business and regulatory requirements. The role establishes process ownership, accountability, performance expectations, escalation mechanisms, and training priorities. It provides leadership visibility into QMS health and compliance through metrics, management reporting, dashboards, and governance forums. The manager also drives process standardization, simplification, digitalization, and continuous improvement, while promoting a culture of quality, compliance, accountability, collaboration, and ongoing improvement.

Requirements

Bachelor’s degree in Engineering, Quality Management, or a related field, or equivalent experience.
At least 5 years of experience in quality management or related roles, or at least 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 for Medical Devices and 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.
Leadership capabilities, including coaching and developing employees, establishing priorities, managing resources, influencing cross-functional stakeholders, and driving accountability and performance.
Strong analytical and problem-solving skills, including use of quality metrics, trends, dashboards, and operational data to identify risk and drive improvement.
Ability to lead cross-functional quality system improvement initiatives and communicate quality performance, compliance risks, priorities, and recommendations to leadership.

Nice To Haves

Experience in the medical device, healthcare, or another 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, 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, root cause analysis, 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 QMS.
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.
Proven leadership of Quality Systems operations, balancing compliance, business priorities, operational performance, and continuous improvement.
Practical, data-driven leadership 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.
Ability to translate complex quality, compliance, risk, and performance information into clear leadership insights and recommendations.
Continuous improvement mindset focused on preventing recurrence, strengthening organizational capability, and improving QMS effectiveness and maturity.

Responsibilities

Lead, coach, and develop the site Quality Systems team, setting objectives, priorities, responsibilities, and performance expectations and ensuring appropriate capabilities and resources.
Lead governance, maintenance, and continuous improvement of assigned QMS processes, including process ownership, accountability, performance expectations, and escalation mechanisms.
Provide operational leadership and oversight for CAPA and nonconformance management, including investigations, root cause analysis, corrective and preventive actions, effectiveness verification, timely closure, and escalation of significant or systemic issues.
Lead internal and external audit readiness and regulatory inspection support, including preparation, organizational alignment, response development, remediation, and timely closure of findings.
Ensure assigned QMS processes comply with applicable standards and regulations, including ISO 13485:2016, ISO 14971:2019, FDA QMSR, and other applicable requirements.
Integrate risk-based principles and medical-device risk management requirements 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 actions and escalation.
Provide leadership with visibility into QMS health, performance, compliance risks, and improvement priorities through management reporting, dashboards, and quality governance forums.
Drive standardization, simplification, digitalization, and continuous improvement of quality system processes to improve compliance, effectiveness, efficiency, and organizational performance.
Promote use 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 QMS accountability.
Establish training and competency priorities for assigned QMS processes and ensure 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.