Medical Device Steam Sterilization/GAMMA/ETO SME
Los Angeles, CA
Medical Device Steam Sterilization SME
Background: Our client is a large Medical Device manufacturer of a number of Class I, II and III medical devices. They are in need of a Steam Sterilization SME to perform a Gap Assessment on one of their medical device Steam Chambers. The individual will be from a Medical Device GMP background, with strong hands-on Steam Sterilization. They will also be responsible for the creation of an Action Plan. They are also looking for this individual to have experience with (GAMMA) qualifying a new sterilizer at their Tijuana, Mexico site.
The consultant must be comfortable in a fast-paced environment and able to hit the ground running. Responsibilities:
- Performing/Identifying Gap Assessment
- Writing Action Plan
- Providing Strategic Recommendations on Remediation to Upper management.
- Qualifying new sterilizer
- Medical Device: 5-8 years
- Steam Sterilization
- Parametric Release
Job Type: Contract