Senior Quality Manager

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics.

Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Senior Manager, Quality Engineering provides strategic and operational leadership for Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations in Sparks, MD. This role is responsible for ensuring compliance with FDA, ISO 13485, and MDSAP requirements while driving continuous improvement, audit readiness, and Quality Management System effectiveness across the organization.

As a key member of the leadership team, this position partners closely with Manufacturing, Engineering, Regulatory Affairs, and Operations leaders to establish quality strategies, support business objectives, develop talent, and maintain a culture of quality and compliance. The Senior Manager, Quality Engineering plays a critical role in advancing operational excellence and ensuring the delivery of safe, effective, and compliant products.

• Lead Quality Systems and Quality Engineering activities supporting the Micro Reagents manufacturing operations.
• Develop, implement, and maintain Quality Management System (QMS) procedures, policies, and standards in compliance with regulatory and corporate requirements.
• Ensure compliance with FDA Quality Management System Regulation (QMSR), ISO 13485:2016, MDSAP, and other applicable regulations and standards.
• Provide interpretation and guidance on company-wide quality policies and procedures.
• Maintain appropriate quality oversight of all Quality Management System processes to support a continuous state of compliance.
• Support and strengthen site audit readiness through proactive quality system management and monitoring.

• Lead and support internal, external, customer, corporate, and regulatory audits and inspections.
• Ensure effective execution and continuous improvement of Corrective and Preventive Action (CAPA) processes.
• Partner with cross-functional teams to address quality and compliance risks and implement sustainable solutions.
• Support new product development and product enhancement activities by providing quality engineering guidance and oversight.

• Partner with site leadership to establish and execute quality objectives aligned with business priorities and key performance drivers.
• Develop and manage departmental budgets, schedules, performance metrics, and resource plans.
• Establish operational goals and ensure successful execution of strategic initiatives and quality improvement programs.
• Analyze performance trends and identify opportunities to improve efficiency, compliance, and overall quality system effectiveness.
• Contribute to the…