Global Quality Leader, Medical Devices & Surgery

Baxter Healthcare; Deerfield (IL); In loco; USD 250.000 - 350.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) Retirement Savings Plan

Employee Stock Purchase Plan (ESPP)

Paid holidays and paid time off

Commuting benefits

Employee discounts and EAP

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality leadership

Regulatory compliance

Medical devices

Global operations

Quality systems

Risk management

Communication skills

Decision making

Formazione

Master's degree in science/engineering/healthcare

Strumenti

ISO 13485

FDA QSR

Descrizione del lavoro

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.