Quality Engineer II

Serve as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues.

Maintain familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.

Provide technical mentorship for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned.

Ensure the contents of Validation protocols meet all applicable quality system requirements and product requirements.

Lead projects/project teams in the use of continuous improvement tools and methodologies such as Six Sigma, 8D, 5-Why, etc.

Work with assigned manufacturing department(s) to maintain the highest quality standards/requirements.

Initiate, review,...