Senior Quality Engineer, Instrument Plant

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 As 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 organization Problem-Solving at Scale: Apply sophisticated statistical tools to analyze data, identify root causes, and implement corrective actions for complex quality challenges Audit Authority: Take the lead on both internal and external audits, potentially serving as Lead Auditor and ensuring our processes exceed industry standards Data-Driven Decision Making: Monitor and trend quality indicators, assess Critical To Quality (CTQ) parameters, and conduct risk assessments that shape predictable product design and flow Cross-Functional Collaboration: Partner with project teams and operations to integrate new products seamlessly into manufacturing while sharing quality insights and solutions Regulatory 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 development Quality Intelligence: Generate and communicate Critical to Quality indices, providing actionable recommendations to project teams and operations as issues emerge Metrics Mastery: Drive improvement in key quality metrics including First Pass Acceptance rates, Quality Notifications, and Complaint data Process Innovation: Develop departmental programs focused on continuous improvement and standardization across DS Diagnostic Systems New Product Integration: Support the coordinated launch of new products into Manufacturing and Operations environments Compliance Guardian: Ensure all DS Diagnostic Systems divisional and departmental policies, procedures, practices, and facilities meet applicable regulatory requirements Documentation Leadership: Develop and maintain Design/Device History Files in full accordance with FDA requirements CAPA Ownership: Initiate Corrective and Preventive Actions (CAPAs) and lead investigation and corrective action processes Supplier Quality Management: Monitor quality indicators for purchased materials and ensure consistent supplier qualification practices Required Qualifications: BS in related field required with minimum of 3 years of Quality Operations or Regulatory experience in the medical device environment or 5 years in manufacturing environment MS with 3 years of experience. Typical degree in Electrical or Mechanical or Industrial Engineering. Experience and understanding of electro-mechanical instrumented systems. Experience handling multiple projects simultaneously in a fast-paced environment. Proficiency with Microsoft Office (Word, Excel, PowerPoint) Preferred Qualifications: Pharma/Medical device industry experience Experience with Minitab or other statistical analysis platforms Professional certifications such as Certified Quality Auditor/Certified Quality Engineer, Six Sigma 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. #BDCLO 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 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 Location USA MD - Sparks - 7 Loveton Circle 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 learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $95,900.00 - $153,400.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. 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.