Quality Engineer

Summary of Role: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals.
Responsibilities:Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.Reports on the status of validation activities to fulfill regulatory requirements.Performs system administration and configuration of quality information technology systems.Performs investigation non-conformance eventsKnowledge of Good Manufacturing PracticesGood oral and written communication skills (English and Spanish)Computer knowledge (Excel, Word, Power Point, etc.)Availability to work overtime and weekends when necessaryGood problem-solving skillsInitiates, recommends, and provides solutions to the Non-Conforming Product as per proceduresVerifies the implementation and effectiveness of non-conforming CAPAExecutes job responsibilities as established in the proceduresFollows the documentation procedures Non- Conformance ResolutionEvaluating, Investigating & Completion of Non- ConformanceInvestigation ( Data gathering of Quality issue)Identify Corrective/Preventive ActionsImplementing Corrective/Preventive ActionsLead complaint activities with the Operating Units members
Education: Bachelor’s degree in Engineering.
Skills:Established and productive individual contributor.Works independently with general supervision on larger, moderately complex projects / assignments.Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones .Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.