Quality EngineerPurposeSupervision of documentation and in-process quality functions in compliance with Good Manufacturing Practices and ISO 9001 & ISO 13485 to ensure that we maintain and manage the Document Control Process at all stages of the processes, working in conjunction with departments to ensure an effective document control system.ResponsibilitiesAssure that all activities performed are in compliance with ISO, GMP's, FDA, Corporate and Unit SOPs.Identify Quality System deficiencies and implement changes that continually improve the system.Compile, summarize, and submit relevant information on identified quality data sources for Management Review.Ensure communication of audit deficiencies, receipt of corrective/preventive actions, and timely closure of actions and effectiveness checks.Requires use of statistical data analysis, excellent at objective analysis and interpretation.Maintain updates to the Quality Manual and Quality Assurance Procedures.Lead Management Reviews.Support ISO, FDA, and customer audits.Responsible as Supervisor of Document Control and CAPA's.Skills & KnowledgeBS Degree or minimum of 3 years manufacturing experience.Must demonstrate initiative in keeping the activities of the complaint, CAPA system, and audit system up to date with experience in medical devices.Minimum of two (2) years practical experience in Quality Assurance role for GMP regulations, 21 CFR Part 820, and ISO 13485.Minimum of two (2) years practical experience in Quality Systems related areas, such as CAPA, Customer Complaints, Internal and External Audits, desire in medical device.Internal auditor on ISO9001, ISO13485.Must be proficient in PC software (Word, Excel, PowerPoint, Minitab, Visio, Access), word processing, spreadsheet applications, and databases to perform tasks associated with trending, creation of templates for tracking, revision and modification of documentation with a minimum of two (2) years of experience.Advanced English.Corning Puts YOU First!We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.Our monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues' contributions.Health and well-being benefits include medical, dental, vision, mental health/substance, fitness, and disease management programs.Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.Professional development programs help you grow and achieve your career goals.#J-18808-Ljbffr
