Job Description Summary # Job Description Manufacturing process risk identification, evaluation and mitigation for day to day operations, new product introduction and continuous improvement of the value stream. This position handles multiple projects/programs while keeping to key deadlines. The ideal candidate will integrate knowledge of business and functional priorities to address complex problems and non-standard situations. The candidate will act as a key contributor in a complex environment, and works independently with minimal guidance. Responsibilities Other duties include but not limited to the following: + Partners with Manufacturing Engineering, Materials Management and Operations to support existing value streams; implements and maintains process risk-based controls that drive validation / revalidation, provides statistical analysis, control plan generation, drives / supports OEE, CI, C2W, nonconformance, CAPA, compliant investigations, etc... + Experience leading / creating PFMEA and Control plans; applying knowledge of product, process, and observations from operators. + Apply statistics to make decisions + Supports the development of test methods and validates test methods + Prepares product and process reports by collecting, analyzing, and summarizing information and trends. + Lead / support internal and external validation (supplied component validations) activities for new products, processes, changes and transfers as required. + Participate on project teams as a Core Team Member or Leader representing manufacturing Quality and or quality processes + Develop and implement new quality processes for production and scale-up programs and ensure successful quality goals + Process & Product Data - Maintains a working knowledge of new methods, equipment, product specifications, waste, costs, through put rate, and material costs. This technical data is to be used in the justifications of new equipment and cost reduction projects. + Documentation - Prepares process descriptions and quality manufacturing specifications as required + Manufacturing Quality Support - Provides technical guidance as needed to manufacturing and hourly technical personnel during the start-up of new or changed products and processes. Uses good decision making, problem solving and trouble-shooting techniques to minimize the potential or correct ongoing manufacturing quality issues. Requirements + BS Degree Engineering + 5-10 years’ experience within a regulated environment Desired: + QMS - ISO 13485 or equivalent from other industries + Risk Management - ISO 14971 or equivalent from other industries + Quality System Auditing + PPAP experience Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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. #LI-Pro # Primary Work LocationUSA OK - Mannford # Additional Locations # Work Shift Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.