What are the responsibilities and job description for the Supplier Quality Engineer position at Katalyst CRO?
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.).
