Manufacturing Quality Engineer
Quality Engineer (Manufacturing)
Our client is a large contract medical device manufacturer. The client is currently in need of a consultant to come in and help with Manufacturing Quality/Process Validation aspects of a large Clinical build.
Principle Duties and Responsibilities:
The consultant will be from the Medical Device industry and will come from a GMP background. Responsibilities will include Clinical Manufacturing Process Validation, writing, reviewing and executing test protocols/procedures. The consultant will be responsible for identifying deviations and executing CAPAs, Design Verifications and Test Method Validations. The consultant will ideally have a strong Statistics background, and will have experience with combination devices (inhaler). They must be comfortable working as an individual contributor in a team atmosphere.
· 5-7 years Medical Device
· 5-7 years Quality Engineering
· 5-7 years Clinical Manufacturing Process Validation
· Writing & Executing Test Protocols
· Test Method Validation
· Design Verification
· Combination Devices (Inhaler)
· Statistics Background