Validation Engineer

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. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk

Develop, update, and maintain technical content of risk management files

Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes

Requirements

Bachelor's degree required; Minimum of 6 years of experience; Minimum of 3 years of experience in medical device industry; Must have written, created and developed SOPs; Run Test Method Validations; Gage R&R experience, and Risk Analysis Gage R&R; Compose protocol reports