Rochester, Michigan14 days ago
Responsible for providing oversight of the following programs: change control, validation, quality risk management, aseptic and microbiology support (processing, technique/clean room behaviors, environmental/critical utilities/personnel monitoring, facility cleaning and sanitization, sterilization, media simulation, microbial tracking/trending), and Medical Device & Combination Products (MDCP). Medical Device and Combination product program – conduct regulatory assessments, create/maintain design history file, participate and develop MDCP FMEAs, develop and report on key performance indicators (metrics), conduct internal audits, impact assess design changes.