Sr. Supplier Quality Engineer
BDNow 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 Key Responsibilities: Provide guidance and Quality oversight for key suppliers to ensure suppliers are aligned with Waters Quality, Regulatory and Industry standard requirements. Ensure controls meet WATERS, FDA, and other applicable regulatory requirements and identifying quality needs, product improvements and customer requirements Drive and Support new product development and sustaining activities in supplier management ensuring supplier compliance and capability for Qualification, Approval, and Sustaining activities. Ensures adequate design control documentation and records are maintained to support life cycle of design history Provide quality support for Supplier Qualification and Approval steps and ensure that they are completed adequately including areas in supplier selection, quality planning, risk analysis, critical to quality characteristics, supplier specification and DFM reviews, validations, verifications, quality agreements, supplier history files and other activities as needed Support activities relating to Field Corrective Actions, when needed Facilitate and Partner with suppliers to develop strong business and quality relationships ensuring strong communication and collaboration Establish new initiatives to support ongoing improvement of Supplier Quality Management Systems. Education and Experience: B.S. or B.A. degree in an engineering or science field. Minimum of 3 years of experience in Supplier Quality in a manufacturing environment working in an FDA or ISO regulated environment Six Sigma Green Belt and/or Certified (e.g. ASQ) Quality Engineer or equivalent (Prefer Six Sigma Black Belt Certified) desired Minimum Qualifications: Robust understanding of QSR, Design Control, ISO, Product Risk Management and GMPs as defined in CFR 820 Excellent people interaction, team building, leadership, and communication skills including providing effective presentations. Strong background in Manufacturing processes including process development and optimization Experience in managing variety of commodities including Instrument Finished Goods, Optics/Lasers, CMs, PCBAs/ Electronics, Sheet metal, Machined Parts, and Cabling harnesses or Chemistry or Biological products Proficient in project management, analytical, critical thinking, problem solving and prioritization skills Demonstrate innovative and implementation skills Demonstrate knowledge of Statistics and Data Analysis to drive data-based results …