Validation Engineer

About American medical equipment company. This is a gap analysis product line-decide where the gaps are and why, will be identifying the gaps. Many errors have been found in documentation and need to work closely with R&D. This project is very dynamic and changing. FDA will be coming on site need to make corrections. Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports. Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.…