Vice President, Global Quality Assurance, Medical Devices & Surgery

Baxter International Inc.•Deerfield, IL

28d•$280,000 - $410,000

About The Position

The Vice President, Global Quality Assurance for Medical Devices & Surgery (MDS) sets the strategic direction for the MDS Quality organization and serves on the MDS and Global Quality leadership teams. The role leads quality strategy across three global medical device businesses, supporting products from development through post-market use. The position oversees global manufacturing quality, research and development quality, design quality, product quality, supplier quality, and external manufacturing quality. It establishes governance, operating practices, and organizational capabilities to deliver consistent quality performance across a complex portfolio of products, technologies, manufacturing operations, and regulatory pathways. The Vice President partners 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 place patients and customers at the center of decisions. Estimated domestic and international travel is up to 30–50%.

Requirements

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.
Strong communication skills and ability to influence senior leaders, regulators, and external partners.
Applicants must be authorized to work for any employer in the U.S.; Baxter is unable to sponsor or take over sponsorship of an employment visa at this time.

Nice To Haves

A master’s degree in a scientific, engineering, healthcare, or related discipline.
Advanced quality, regulatory, or business credentials.
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.

Responsibilities

Set 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 their portfolios, technologies, manufacturing networks, and regulatory pathways.
Advance scalable Quality Management Systems to 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.

Benefits

Medical and dental coverage starting on day one for eligible roles.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contribution and company matching options.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program (EAP).
Childcare benefits.
The position may be eligible for discretionary bonuses, commission, and/or long-term incentive.