Manager, Quality Systems Operations

Regulatory Jobs; Palo Alto (CA); In loco; USD 134.000 - 184.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

QMS knowledge

CAPA & nonconformance

Audit readiness

Leadership

Risk management

Cross-functional collaboration

Formazione

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

Strumenti

SAP

ERP systems

eQMS

MES

Microsoft Office

Dashboards

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 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, strengthening organizational capability, and improving the overall effectiveness and maturity of the Quality Management System.

Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

The base pay range for this position is:

$133,740 - $183,887

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

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Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

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