What are the responsibilities and job description for the Design Quality Engineer Medical Devices position at iTech US, Inc.?
Job Details
Role : Design Quality Engineer Medical Devices Location : Irvine, CA (Onsite) Type : Contract
Description:
Description:
- Design Quality, good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process
- EIS : Medical Device & Regulations
- A Minimum bachelor s degree in engineering, Science or related technical field5 years of experience & demonstrated proficiency in Design Quality & providing ongoing technical support is preferred
- 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)
- 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.)
- Design Quality, good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process
Education: At least a bachelor s degree (or equivalent experience) in Computer Science, Software/Electronics Engineering, Information Systems, or a closely related field is required for the project
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