Verified recordMedical Device

Jim Kaiser

Staff Quality Engineer at Ortho Clinical Diagnostics

Based in Rochester, United States

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Seniority

Staff

Department

Engineering

Location

Rochester

Industry

Medical Device

Company size

2.9K

Contact information

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Email

1 credit

j•••••••@orthoclinicaldiagnostics.com

Phone

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Background

About Jim Kaiser

Reliable, inter-disciplinary scientist with more than 30 years of experience in the medical device and pharmaceutical industry. Able to function well either in a team or individual setting. Well-experienced in traveling either domestically or internationally to conduct assignments. Primary skills are: 1) Validation of industrial sterilization processes: steam, radiation, and ethylene oxide 2) The ability to assess and improve complex processes within the context of ISO 13485 Quality Systems 3) Being familiar with Quality System audits 4) Good practical knowledge of the materials effects of sterilization processes 5) Good statistical analysis skills - working knowledge of Minitab software

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