Requisition Number: 35306 Corning is one of the world's leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people's lives.Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning's Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.Scope of Position:In this role, you will develop, modify, apply and maintain quality evaluation systems and procedures for processing materials into finished product. We look for you to collaborate with engineering and manufacturing functions to ensure quality standards are in place. You will devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Areas of specialization include: design, validation, root cause analysis, statistical risk management, production control or product evaluation and reliability as they apply to product or process quality. Additional training and certification will include lean and six-sigma quality engineering methodologies. You will also be responsible for PEx project portfolio assuring the effective use of different improvement methodologies (DMAIC, Lean, DESGN, etc.) toward the achievement of plant strategic goals. We look for you to exercise judgment within defined procedures and practices to determine appropriate action. Key Responsibilities:Lead and participate in project teams to quickly and effectively implement improvement initiatives or manufacturing process improvements.Provide manufacturing support activities to include validation projects, equipment validation projects, and or involvement in improvement projects related to products or services consistent with FDA requirements for medical device products.Participate in continuous improvement and Performance Excellence activities to include leading, participating, or coaching project teams, facilitating events, or providing training.Provide technical support and guidance to other Mediatech staff and/or project team members in Quality Systems improvement efforts.Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.Participates in execution of validation protocols.Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.Perform technical reviews and interprets data for accuracy of equipment/process performance.Write Technical Reports and Protocols, as needed, and write, revise, and review SOPs. Frequently interacts with colleagues, team members, supervisors, and other teams/departments.Leads the change management program to assure there is a proper technical review of requested changes and that there is a risk assessment of requested changes.Manages CAPAs assigned to the QE department to closure and assures corrective actions are effective.Participates in MRB, reviews and/or completes nonconformance reports, FIRs, and CAPA documents to assure root cause analysis is reached and corrections are appropriate to prevent further nonconformances.Reviews QS metrics and makes recommendations for corrective actions.Serve as a resource for performing internal audits to ensure quality system compliance.Some travel is required as part of the job responsibilities. Travel Requirements:10% domestically as needed. Hours of work/work schedule/flex-time:Standard business hours, Monday Friday. Required Education:Bachelor's degree in relevant fields of study such as Microbiology, Chemistry, Biology, or Engineering. Required Years and Area of Experience:Minimum 3+ years of quality engineering and validation work experience. Required Skills:Can apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.Basic computer knowledge in Microsoft Word and Excel.Demonstrated technical writing skills; write protocols (IOPQ- computer or sterilization validations).Familiar with statistical analysis.Ability to apply quality engineering practices and guidance to support project teams and manufacturing operations using similar tools to Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.Experience supporting manufacturing support activities to include validation projects, such as equipment validation and cleaning/sterilization validations. Desired Experience / Qualifications / Skills:Advanced degree.Experience with FDA requirements for medical device products.Familiarity with cGMP, ISO 9001, ISO 13485, QSR 21 CFR 820, 210, 211 is highly. desirable.Certified Quality Engineer recognition by ASQ.Six-Sigma / Lean experience.Proficiency in Minitab, MS Project.Experience with software validations and test method validations. Soft Skills:Can balance team and individual responsibilities.Detail oriented.Able to work well both independently and in a group setting.Track record of delivering results. This position does not support immigration sponsorship.We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status.
Associated topics: biomaterials, biomedical engineer, bioprocessing, genetic, metabolic, msat, neuro, neurodegenerative, pathogenesis, therapeutic