Katalyst CRO

Supplier Quality Engineer

about 1 month ago

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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 (Preferred 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 (Preferred Auto CAD and SolidWorks).
Strong Fixture design skill.
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 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.).