Supplier Quality Engineer

Job DescriptionJob Description

Roles & Responsibilities:

• Design Quality, Good manufacturing practices (GMP), CAPA/NC, Statistics, DFMEA, PFMEA, CAD, Root Cause Analysis, Manufacturing Process.
• EIS : Medical Device & Regulations.
• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs.
• Strong creative, analytical and problem-solving skills.
• Proficient at interpreting data and putting that data into a report.
• Proficient at statistical analysis.
• Root Cause Analysis.
• Strong CAD Skills ( Auto CAD and Solidworks).
• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 13485 and regulatory affairs.
• Strong creative, analytical and problem-solving skills.
• Proficient at interpreting data and putting that data into a report.
• Proficient at statistical analysis.
• Root Cause Analysis.
• Strong CAD Skills ( Auto CAD and Solidworks).
• Experience in creating FMEAs & Writing reports.
• Experience in PMS (Post Market Surveillance).
• Experience in PLM Tool (Windchill).
• Process experience, ability to observe and understand manufacturing processes.
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills .
• 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.).