Sr. Quality Engineer

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.

We are the people who give possibilities purpose

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 Quality Engineer ensures compliance with Quality System, ISO, and FDA requirements by developing and implementing SOPs, quality policies, and process controls across the Media and IDAST plants. This role partners cross-functionally to drive consistent manufacturing practices, support audits, lead quality improvement initiatives, manage CAPAs, and ensure successful product launches. Using data analysis and quality tools such as SPC, statistical sampling, Six Sigma, and root cause analysis, the engineer identifies opportunities for continuous improvement and resolves quality issues effectively.

• Monitor, analyze, and trend quality indicators for purchased materials, as well as manufactured and distributed components and products, to drive product quality and performance improvements.
• Evaluate Critical to Quality (CTQ) parameters and risk assessment variables to support informed decision-making, predictable product design, and efficient product flow.
• Serve as a key Quality Management (QM) Engineering resource, supporting both Media QM Engineering initiatives and day-to-day quality engineering activities for assigned products and operational areas.
• Partner closely with the Plant Senior Quality Manager to ensure the consistent implementation and application of Quality Systems across new and existing product lines, as well as Enterprise business systems.
• Support compliance with ISO, FDA, and internal quality requirements through:
  Internal and external audit participation, Cross-functional team collaboration, Project support and execution, Product launches and transfers, Process improvement initiatives, CAPA coordination and resolution, Product quality notifications, Change notifications, Customer complaint investigations and follow-up
• Utilize root cause analysis methodologies and quality tools to identify issues, drive investigations, and implement effective corrective and preventive actions.
• Develop, execute, and monitor corrective action plans to address quality concerns and drive sustainable improvements.
• Leverage Enterprise tools and systems to ensure regulatory compliance, improve visibility, and streamline quality processes.
• Collaborate across functions to promote continuous…