Vice President, Global Quality Assurance, Medical Devices & Surgery

Baxter Healthcare; Deerfield (IL); On-site; USD 250,000 - 350,000; Full time

Benefits offered by this job

Health insurance

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid holidays and paid time off

Commuting benefits

Employee discounts and EAP

Job summary

Baxter Healthcare seeks an executive to lead Global Quality Assurance for MDS, directing quality strategy across multiple device lines and global operations. You will strengthen systems, guide critical decisions, and ensure regulatory compliance to protect patients and maintain supply continuity.

The role requires 15+ years in quality/operations with 10+ years in senior leadership, deep medical device expertise, and strong collaboration with regulators and senior leaders worldwide.

Qualifications

• 15+ years in Quality, Engineering, Manufacturing, or related function in regulated industry.
• 10+ years in progressively senior Quality or Operations leadership roles.
• Executive-level experience leading global matrixed Quality organizations.
• Deep medical device lifecycle expertise from development to post-market.
• Advanced knowledge of global quality and regulatory requirements (FDA EU MDR ISO 13485).
• Strong decision-making and ability to influence senior leaders and regulators.

Responsibilities

• Set the global MDS Quality strategy, priorities, governance, and operating model.
• Lead quality across three medical device businesses with accountable leadership.
• Advance scalable Quality Management Systems across the lifecycle.
• Guide manufacturing, design, product, supplier, and external manufacturing quality.
• Direct risk-based decisions and escalation for quality, regulatory, supply, or safety.
• Partner with regulators, notified bodies, and cross-functional teams for inspections and remediation.
• Build a diverse global Quality organization with clear accountability and development.

Skills

Quality leadership

Regulatory compliance

Medical devices

Global operations

Quality systems

Risk management

Communication skills

Decision making

Education

Master's degree in science/engineering/healthcare

Tools

ISO 13485

FDA QSR

Job description

This is whereyour work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Quality leadership at Baxter directly influences the safety, reliability, and availability of products used in patient care around the world. 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-perform- ing organization that enables innovation while protecting patients and maintaining regulatory compliance.

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

• 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.

US Benefits at Baxter (except for Puerto Rico)

• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.
• For additional information regarding Baxter US Benefits, visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin