Quick Info
Experience Level
Mid LevelMinimum Degree
BachelorDepartment
Quality Assurance ControlJob Type
Full TimeSpecialty Skills
ISO 9001ISO 13485FDA 21 CFR Part 820/211EU GMPsISO 17025ISO 11137ISO 11135CAPAStatistical Techniques
About the Role
The Quality Analyst in the STERIS Applied Sterilization Technologies (AST) Whippany, New Jersey location is responsible for assisting in administration of the quality management system to assure adherence to ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137 and/or ISO 11135 and other applicable regulatory standards. The Quality Analyst leads complaint/CAPA investigations, supplier quality improvement initiatives, continuous improvement initiatives and countermeasures with the use of statistical techniques and other accepted quality principles. This role executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.
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