Vice President, Global Quality Assurance, Medical Devices & Surgery
PharmaMedTechRegulatory AffairsQuality Assuranceiso 13485croraveinform
Job description
This is where your 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-performing 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 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. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $280,000 - $410,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. At Baxter, you'll join a team united by a shared purpose: improving outcomes for patients and healthcare providers around the world. We believe innovation happens through collaboration, diverse perspectives, and a relentle
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