Quality Engineer
Description:
Job Title: Sr. Quality Engineer
Location : Irvine, CA
Duration : Full Time
Salary Range: $100,000-$130,000 a year
Job Description:
Must Have Technical/Functional Skills
" Knowledge on Quality Management and its tools & techniques
" Knowledge about GMP (Good Manufacturing Practices), FDA, ISO 13485 and compliance regulations
" Knowledge on Medical Device Regulatory Standards, MDD and MDR
" Knowledge on NC, CAPA, Root Cause Analysis and Audit processes
" Knowledge in Statistics, Risk Management and Design control
" Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills
" Experience in creating FMEAs & Writing reports
" Experience in PMS (Post Market Surveillance)
" Experience in PLM Tool (Windchill preferred)
" Good understanding of Design, Drawing and GD&T
" Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
" Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
" Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)