Quality Systems Engineer

Company: Glidewell Dental
Location: Irvine
Posted on: May 13, 2022

Job Description:

Essential Functions : Conducts engineering activities in compliance with FDA Regulations, ISO 13485 and other national and international quality and regulatory requirements and standards. Leads product quality assurance and quality engineering activities to drive strong engineering and technical knowledge. Establishes quality assurance, engineering programs, and initiatives to ensure products are developed and manufactured according to applicable requirements. Conducts investigations of NCR---s and complaints and provides corrective and preventive actions based on sound engineering analysis and review; recommends effective solutions to drive continuous and measurable improvements. Works closely with Manufacturing/Operations, R&D and other departments to ensure highest quality products and processes are developed, deployed, and meet all engineering requirements; includes product design testing, process testing, process streamlining, problem resolution, characterization, qualification, validation, risk analysis/FMEA, etc. Develops and maintains systems for the identification, analysis, correction, and prevention of quality issues; identifies areas of improvement as needed and manage quality engineering projects from start to finish. Participates in CAPA Management and other quality engineering projects as assigned. Teaches quality engineering tools within the organization including Risk Management Assessments using ISO 14971. Analyzes data and trends to report to management. Conducts failure investigations and root cause analysis. Collaborates in design verification testing for design control projects. Conducts returned product analysis and failure investigation activities. Manages NCMR process to ensure procedures and regulations are adequately followed. Ensures calibration and preventive management systems meet compliance requirements. Identifies and ensures the optimization of complex manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identifies opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Performs other related duties and projects as business needs require at direction of management Education and Experience: Bachelor---s degree in Science or a related field; or an equivalent combination of experience and training; advanced degree preferred. Minimum of three (3) years--- experience in Quality Engineering and Risk Management. Experience in medical device and ISO 13485. Previous project management experience. Special Requirements/Certification: ASQ CQE or other certifications preferred

Keywords: Glidewell Dental, Irvine , Quality Systems Engineer, Other , Irvine, California