Quality Engineer II (Validation)

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 MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description The Quality Engineer II, Validation is responsible for supporting and maintaining Quality Systems across Media manufacturing plants, with a primary focus on validation writing, execution, and compliance. This role ensures consistent application of quality standards, drives continuous improvement initiatives, and partners cross-functionally to support manufacturing operations, product quality, and regulatory compliance. Responsibilities Develop, implement, and maintain Quality System procedures, Standard Operating Procedures (SOPs), and quality policies. Lead and execute validation activities, including change validations and recurring process/equipment qualifications for Media plants and IDAST. Monitor, trend, and analyze quality indicators for purchased materials, manufactured products, and distributed components. Assess Critical to Quality (CTQ) parameters and perform risk assessments to support product quality, process predictability, and decision-making. Apply statistical tools and data analysis techniques to identify root causes, resolve quality issues, and implement effective corrective actions. Initiate and support Corrective and Preventive Actions (CAPAs), including leading investigations and corrective action activities when required. Support process control initiatives and promote consistent manufacturing practices across operations. Identify and recommend continuous improvement opportunities to enhance product quality, operational efficiency, and compliance. Manage day-to-day Quality Management (QM) Engineering activities for assigned products and operational projects. Partner with manufacturing, engineering, and cross-functional teams to support product launches, process improvements, and quality initiatives. Ensure consistent implementation and application of Quality Systems for both new and existing product lines. Maintain compliance with FDA regulations, ISO standards, and other applicable quality and regulatory requirements. Support quality-related activities including change controls, product quality notifications, post-market activities, IVDR compliance, and customer complaint investigations. Utilize enterprise systems and quality tools to drive compliance, documentation accuracy, and process efficiency. Serve as a subject matter expert (SME) during internal and external audits, as needed. Foster collaborative and inclusive working relationships across departments that support Media manufacturing operations REQUIRED QUALIFICATIONS Bachelor's degree in Biological Sciences, Chemistry, or other related science field. 2 years experience in Quality, Scientific Operations, or Engineering. PREFERRED QUALIFICATIONS Experience in technical writing and managing process and test method validations. Experience in a medical device or pharmaceutical manufacturing facility. SKILLS AND KNOWLEDGE Basic knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization ISO 13485 and 14971. Ability and management plans skill to effectively manage multiple tasks and drive execution of change Ability and skill to lead or manage process control, supplier quality, and continuous   improvement projects using statistical technique/tools such as: Statistical sampling, SPC,   Six sigma, additionally root cause analysis and project management techniques are   routinely employed. Ability to effectively write communications that ensures clarity, accuracy, and consideration of the audience. Ability to speak with clarity and express points of view in a variety of settings; one-on-one   interactions, group meetings, and formal presentations. Ability to listen to others; including associates, managers, peers and customers when   making decisions and solving problems. Ability and skill to analyze data using systematic analytical tools such as Six Sigma, root   cause analysis, failure analysis and risk assessment to gather critical information that has   moderate to difficult complexity. Knowledge of automated systems for filling and packaging are a plus. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also