Senior Quality Engineer, Instrument Plant

Skip to main contentWe use cookies and other tracking technologies to assist with navigation, improve our products and services, assist with our marketing efforts, and provide content from third parties. By continuing to use this site you agree to our use of cookies in accordance with our privacy policy. Manage third-party cookie preferences hereDeclineAccept CookiesEnglishSign InSenior Quality Engineer, Instrument Plant page is loadedSenior Quality Engineer, Instrument PlantApplyremote typeOnsitelocationsUSA MD - Sparks - 7 Loveton Circletime typeFull timeposted onPosted 30+ Days Agojob requisition idR-546081As 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 purposeBD 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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionAs our Senior Quality Engineer, you'll be the cornerstone of quality assurance for designated product lines, owning everything from product design manufacturability to supplier partnerships and customer satisfaction. You'll interpret and apply Quality Systems while developing the Standard Operating Procedures that keep our organization compliant and competitive.Responsibilities:Strategic Quality Leadership: You'll develop and maintain Design History Files while serving as the go-to expert for quality standards and protocols across the organizationProblem-Solving at Scale: Apply sophisticated statistical tools to analyze data, identify root causes, and implement corrective actions for complex quality challengesAudit Authority: Take the lead on both internal and external audits, potentially serving as Lead Auditor and ensuring our processes exceed industry standardsData-Driven Decision Making: Monitor and trend quality indicators, assess Critical To Quality (CTQ) parameters, and conduct risk assessments that shape predictable product design and flowCross-Functional Collaboration: Partner with project teams and operations to integrate new products seamlessly into manufacturing while sharing quality insights and solutionsRegulatory Excellence: Maintain FDA and ISO regulatory compliance with laser focus on product design for manufacturability, customer complaints, assembly/test procedures, inspection protocols, and validation throughout developmentQuality Intelligence: Generate and communicate Critical to Quality indices, providing actionable recommendations to project teams and operations as issues emergeMetrics Mastery: Drive improvement in key quality metrics including First Pass Acceptance rates, Quality Notifications, and Complaint dataProcess Innovation: Develop departmental programs focused on continuous improvement and standardization...