Quality Engineer - Katalyst Healthcares & Life Sciences
Minneapolis, NJ 55111
About the Job
Responsibilities and Requirements:
- Must Have Technical/Functional Skills- experience Required.
- Knowledge of Medical procedure and corresponding Medical Equipment.
- Good experience in CAPA execution, CAPA write up.
- Good experience in Test Method Validation (TMV).
- Good experience in Process Validation.
- Knowledge of Medical Equipment manufacturing processes.
- Knowledge on Quality Management and its tools & techniques.
- Knowledge about FDA, ISO 13485, ISO 14971 and compliance regulations.
- Knowledge on NC, Audit processes.
- Knowledge in Statistic, Risk Management and Design control.
- Must possess good communication skills (verbal and written), familiar with project management methodology, problem solving, and presentation skills.
Source : Katalyst Healthcares & Life Sciences