Design Quality Engineer
Tucson Metro Area, AZ
Responsible for establishing and maintaining Design Quality Assurance systems and processes. Ensures conformance and compliance to domestic and international quality and regulatory standards. Defines Quality and Regulatory strategies for complex diagnostic assays in development and provides guidance to product development teams.
Supports the Primary Staining Reagent, antibody, immunohistochemistry, detection reagent, and molecular probes, or CDx Design Quality teams that supports the delivery of portfolio projects for all life cycle teams. Supports the development of primary staining reagents, immunohistochemical and in situ hybridization In vitro diagnostic (IVD) products, etc.
Maintains extensive knowledge of principles, theories, and practices in Design for Excellence activities such as Design for Manufacturability for complex diagnostic systems to include assays and reagents. Provides strong understanding of molecular/cell biology techniques, relevant systems and reagent experience to staff. Provides technical knowledge of Design and engineering principles and their application to ensure that cost-effective, reliable and high-quality systems that satisfy customer needs and business requirements are delivered.
BS in a directly related discipline. Advanced studies or training.