Validation Engineer

1st shiftE-VerifyLocation: Elgin, IL | On-SiteDuties/Responsibilities:Participate in projects/program management, review new and existing drawings as received from customers and evaluate potential quality issues.Develop and execute IQ, OQ, and PQ validation protocols for production processes, equipment and software in a timely and cost-effective manner.Write reports summarizing results for equipment, process or software validation projects.Determine deliverables with the customer and cost estimate the sampling requirements andinspection activity. Review existing validation reports and identify/mitigate gaps for compliance to requirementsWork with Q.A. Dept. on piece part inspections and capability studies of new mold and engineering changes to ensure all requirements are completed and approved.Conduct or lead corrective and preventive actions in quality systems or validations using problem solving techniques.Participate as an active new product development core team member.Process all stages of validation documents and oversee the completion and signatures.Support quality system projects and activities such as engineering change order support and complaint investigation support.Support FDA inspection readiness activities.Interfacing customers, staff and fellow managers to establish and maintain validation schedules throughout the company.Ability to interact with customers in all necessary situations to keep them informed of progress and documentation status.Consults with customers on quality and inspection-related issues.Manages and holds project meetings with customers.Other duties as assigned by the Director of Engineering.Required Skills/Abilities:Excellent written and verbal communication skills and highly effective time management skills.Ability to operate independently and as part of a teamIndependent problem-solving skillsProficient in root cause analysis, verification & validation, process flow mappingTechnical and procedural understanding of customer requirements for part validation.Project management skills include planning, processing, organizing and tracking of all part validation activities.Experience processing data in MiniTab software and correlate P values.Knowledge of processes and procedures for cost estimating of validation work.Education and Experience:Bachelor of Science degree from an accredited college or university in an Engineering or Science discipline and 3-5 years of process/software validation experience in a regulated industryWorking knowledge of Medical Device Regulations and Standards (FDA, ISO 13485, ISO 14971, MDD, IVDD)Physical Requirements:Prolonged periods sitting at a desk and working on a computer.Office environment.Must be able to lift 15 lbs.Must be able to access and navigate each department at the organization’s facilities.Benefits and Compensation: Full benefit offerings including medical, dental, vision, and voluntary plans $85,000 annually