Quality Engineer II (Validation)

Job description

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 DescriptionThe 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 recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us?To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. Required Skills Optional Skills . Primary Work LocationUSA MD - Hunt Valley Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can