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