Manufacturing Quality Engineer

WI

Job ID: 115526 Industry: Quality



 


 


Quality Engineer (Manufacturing)

Environment:

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.

 

Required:

·        5-7 years Medical Device

·        5-7 years Quality Engineering

·        5-7 years Clinical Manufacturing Process Validation

·        Writing & Executing Test Protocols

·        CAPAs

·        Test Method Validation

·        Design Verification

 

Plus:

 

·       Combination Devices (Inhaler)

·         Statistics Background



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