Validation Engineer

Review of process validations for identification of gaps to internal and external requirements.

Test Method Validation and Process Validation protocol generation, execution, and report generation per applicable Quality System Procedures and Instructions

Identify process validation needs.

Demonstrate the understanding of medical device regulations and best practices.

Demonstrate knowledge of medical device regulation (ISO 13485, 21 CFR) and risk

management (ISO 14971).

Demonstrate a proficiency in statistical, quality and continuous improvement methods and Tools