JOB POSITION SUMMARY Prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.

DUTIES & RESPONSIBILITIES Develops standard operating procedures, specifications, and provides technical transfer and validation support. Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. Audits and approves quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products. Provides sampling plans and approves inspection methods for...