Vice President, Global Quality Assurance, Medical Devices & Surgery
Baxter International Inc.
Summary
As Vice President, Global Quality Assurance for MDS, you will lead quality strategy across three global medical device businesses, supporting products from development through post-market use. You will strengthen quality systems, guide critical product decisions, and build a high-performing organization that enables innovation while protecting patients and maintaining regulatory compliance.
Job description
Your Role at Baxter
As Vice President, Global Quality Assurance, you will set the strategic direction for the MDS Quality organization and serve as a key member of the MDS and Global Quality leadership teams. Your scope will include global manufacturing quality, research and development quality, design quality, product quality, supplier quality, and external manufacturing quality. You will establish the governance, operating practices, and organizational capabilities needed to deliver consistent quality performance across a complex portfolio of products, technologies, manufacturing operations, and regulatory pathways.
This is an opportunity to shape quality at an enterprise level. You will bring together teams across Quality, Manufacturing, Research and Development, Regulatory Affairs, Patient Safety, Medical, Supply Chain, and Commercial to manage risk, improve systems, support reliable product supply, and make decisions that place patients and customers at the center.
What You’ll Be Doing
- Set the global MDS Quality strategy, priorities, governance, and operating model in alignment with Baxter’s quality vision and business objectives.
- Lead quality across three medical device businesses, strengthening accountability and consistency while addressing the distinct needs of each product portfolio, technology, manufacturing network, and regulatory pathway.
- Advance scalable Quality Management Systems that improve compliance, simplify ways of working, support innovation, and promote continuous improvement throughout the product lifecycle.
- Guide manufacturing, design, product, supplier, and external manufacturing quality to support inspection readiness, effective product controls, supply continuity, and reliable delivery of compliant products.
- Direct risk-based decisions and escalation strategies when product quality, regulatory compliance, supply, or patient safety may be affected, including recommendations related to potential field actions.
- Partner with global regulatory authorities, notified bodies, business leaders, and cross-functional teams to support inspections, address quality concerns, and deliver sustainable remediation.
- Build a diverse, capable, and connected global Quality organization through leadership development, succession planning, clear accountability, and an environment where people can contribute and grow.
Estimated expected domestic and international travel up to 30-50%
What You’ll Bring
Required qualifications
- At least 15 years of experience in Quality, Engineering, Manufacturing, or a related function within a highly regulated industry, including 10 or more years in progressively senior Quality or Operations leadership roles.
- Executive-level experience leading large, global, matrixed Quality organizations with accountability for quality systems, regulatory compliance, operational performance, and organizational capability.
- Deep medical device expertise spanning product development, design transfer, manufacturing, distribution, post-market activities, and product lifecycle management.
- Advanced knowledge of global medical device quality and regulatory requirements, including U.S. Food and Drug Administration Quality System requirements, European Union Medical Device Regulation, ISO 13485, and ISO 14971.
- Demonstrated ability to make timely, well-informed decisions when product quality, patient safety, regulatory compliance, or supply may be at risk, paired with the communication skills to influence senior leaders, regulators, and external partners.
Preferred qualifications
- A master’s degree in a scientific, engineering, healthcare, or related discipline.
- Advanced quality, regulatory, or business credentials, along with experience overseeing multiple medical device businesses, product families, manufacturing technologies, or global operating units.
- Experience developing leaders and working effectively across countries, cultures, and regulatory environments; additional language capabilities are valued.
Requirements
- At least 15 years of experience in Quality, Engineering, Manufacturing, or a related function within a highly regulated industry
- 10 or more years in progressively senior Quality or Operations leadership roles
- Executive-level experience leading large, global, matrixed Quality organizations
- Deep medical device expertise spanning product development, design transfer, manufacturing, distribution, post-market activities, and product lifecycle management
- Advanced knowledge of global medical device quality and regulatory requirements, including FDA Quality System requirements, EU MDR, ISO 13485, and ISO 14971
- Demonstrated ability to make timely, well-informed decisions when product quality, patient safety, regulatory compliance, or supply may be at risk
- Communication skills to influence senior leaders, regulators, and external partners
- Master’s degree in a scientific, engineering, healthcare, or related discipline (preferred)
- Advanced quality, regulatory, or business credentials (preferred)
- Experience overseeing multiple medical device businesses, product families, manufacturing technologies, or global operating units (preferred)
- Experience developing leaders and working effectively across countries, cultures, and regulatory environments (preferred)
- Additional language capabilities (preferred)
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family and Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.