Validation Engineer

CooperVision, a division of CooperCompanies (NYSE:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visitwww.coopervision.com Job Summary Support key functions for the CooperVision Henrietta Facility within Quality Engineering team. Key functions include Validation support, engineering change orders, risk management and Quality Systems (internal/external audits, metrics, training and document control. This position uses Quality Engineering principles (i.e. Lean, Six Sigma, Advance Problem Solving, and Root Cause Analysis tools and techniques to develop / optimize validation and other quality system processes so that they are aligned with the overall Company strategy and quality system. This role will interface closely with engineering, maintenance, packaging, and distribution operation functions. Essential Functions · Defines the testing strategy and approach to validate new or existing packaging machines and or processes. · Develops/authors/maintains verification, qualification and validation protocols (i.e. Validation Plans, IQ/OQ/PQ protocols, validation final reports) to comply with company specifications to include internal quality systems and ISO requirements as well as laws and regulations. · Participate in and support the maintenance of the Quality Management System and Maintain Quality Department metrics as applicable. · Utilizes quality engineering and lean tools and techniques to establish sampling plans, develop quality plans, conduct and participate in design reviews, FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development. · Leads and support Investigates instances of nonconformance and customer complaints and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions. · Analyzes routine and test data for improvement opportunities. Participates in the design experiments (DOE's) for process and product improvement and validation testing. Develops and executes validation plans · Supports, consults, trains, and leads quality improvement projects. · Provides statistical support for sampling plan and analysis, DOEs, Pareto, ANOVA, and SPC applications. Utilize statistical tools to analyze for trends or issues and communicate to cross functional team. · Provides process mapping and modeling, and provides guidance/options. · Develop and evaluate distribution center and packaging performance capability and develops criteria to monitor (Cp/Cpk) and improve existing processes, as measured by appropriate quality KPIs. Qualifications Knowledge, Skills and Abilities: · Demonstrated project management and problem solving skills · Demonstrated excellent communication, facilitation and leadership skills, with the ability to work cross-functionally in a team environment. · Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools including DOEs. Six Sigma GB/BB or CQE preferred. · Must possess the ability to read, analyze, and interpret technical procedures, international requirements and government regulations. · Possess the ability to effectively present information and respond to questions from groups of senior managers. · Has a working knowledge of Quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements. · Microsoft Windows, Microsoft Excel, Minitab · Tableau, BAAN, Agile, JDA familiarity a plus Work Environment: · Normal office and operations environment · Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task · May be required to travel as needed Experience: · Minimum of 3 years applicable experience with Medical device. Packaging and distribution a plus. Education: · Bachelor’s degree (B.S.) from four –year college or university in engineering or related discipline; equivalent combination of education and experience may be considered · Certified Quality Engineer, Green Belt training, Lean training preferred #LI-RK1 Job: **Engineering* Organization: **CVI Quality Assurance Distribution* Title:Validation EngineerLocation:New York-RochesterRequisition ID:UNI0888