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
Provide Quality Engineering and Validation leadership for design, product, and manufacturing line transfer projects, ensuring applicable quality, regulatory, and business requirements are incorporated throughout transfer planning and execution.
Lead Quality activities associated with design transfer and manufacturing line transfer, including assessment of product and process requirements, specifications, critical-to-quality characteristics, manufacturing controls, inspection and test methods, and acceptance criteria.
Develop and execute the quality and validation strategy for transfer projects, including identification of required qualification and validation activities and establishment of objective evidence demonstrating manufacturing readiness.
Lead and support process validation and equipment qualification activities, including validation planning, protocol development and review, execution oversight, deviation resolution, statistical assessment, and final report approval, as applicable.
Apply risk-based methodologies throughout transfer activities to identify and mitigate product, process, supplier, equipment, and manufacturing risks. Utilize appropriate tools such as process FMEA, design FMEA, fault tree analysis, risk assessments, and other Quality Engineering methods.
Ensure appropriate process controls, inspection methods, sampling strategies, acceptance criteria, and monitoring requirements are established and implemented prior to transfer completion and routine production.
Partner with Design Engineering, Manufacturing Engineering, Operations, Regulatory, Supplier Quality, and other cross-functional stakeholders to ensure design outputs are appropriately translated into manufacturing requirements and controls.
Assess changes associated with transferred products, manufacturing processes, equipment, tooling, materials, suppliers, facilities, and test methods to determine potential quality, validation, and regulatory impact.
Support supplier qualification and readiness activities associated with transferred products and processes, including evaluation of supplier controls, component requirements, process capability, validation requirements, and identified supplier-related risks.
Lead and/or support troubleshooting, nonconformance investigations, root cause analysis, and corrective actions arising during qualification, validation, transfer, and manufacturing ramp-up activities. Apply structured problem-solving methodologies such as 8D and other approved root cause analysis tools.
Establish and monitor Quality Engineering and validation metrics supporting transfer readiness, execution, closure, and post-transfer manufacturing performance.
Identify Quality Engineering best practices and opportunities for continuous improvement related to design transfer, line transfer, process validation, risk management, and manufacturing controls, and support their implementation and standardization.
Provide technical guidance, mentoring, and coaching to Quality Engineers and cross-functional project team members regarding design transfer, validation, risk management, process control, and Quality Engineering methodologies.
Maintain current knowledge of applicable medical device regulations, international standards, BD Quality System requirements, and industry best practices related to design controls, design transfer, manufacturing process controls, validation, and product quality.
Ensure required Quality and validation documentation is complete, accurate, traceable, and appropriately approved to support transfer milestones, phase-gate decisions, production release, and project closure.
Represent Quality as a key cross-functional member of transfer project teams and provide independent Quality input into project risks, readiness assessments, transfer decisions, and acceptance of manufacturing processes.
Demonstrate a high degree of technical leadership, independence, and accountability, with the ability to manage multiple complex transfer projects and drive Quality deliverables to completion with minimal direction.
Additionally, the employee participates in other work activities in support of the company's various strategic objectives.
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.
