Quality Engineer II Remote
About the position Responsibilities • Coordinate, develop, and execute validation activities for terminal sterilization methods. • Provide sterilization sciences expertise and validation subject matter expertise in support of product design and changes. • Perform audits of external service contractors and laboratories. • Ensure compliance with quality system and sterilization standards requirements. • Lead the terminal sterilization validation requirements for new materials and products. • Develop sterilization validation protocols and sterility assurance assessments. • Direct activities necessary for required revalidations of validated sterilization processes. • Actively participate in internal and external audits of manufacturing facilities and suppliers. • Implement Root Cause Analysis concepts to investigate sterilization failures. Requirements • Minimum of 5 years of experience in terminal sterilization activities in a medical device environment. • Extensive knowledge of various modes for terminal sterilization and regulatory requirements. • Knowledge of design quality and microbiology as it relates to sterilization and validation. • Minimum of a Bachelor's degree in Microbiology, Engineering, Sciences or similar. Nice-to-haves • Experience with ISO Sterilization Standards and Medical device GMPs. • Knowledge of Lean Six Sigma concepts. Benefits • Medical, dental, and vision insurance • Telemedicine services • Term life and whole life insurance • Accident insurance • Critical illness insurance • Legal plan • Short-term disability • Retirement savings plan • Service bonus and holiday pay plans • Transit spending account • Paid sick leave Apply tot his job