Staff Manufacturing Engineer

Quest Diagnostics Inc. in San Juan Capistrano, CA seeks Staff Manufacturing Engineer (multiple positions) to, as part of the Pharma Services Team, manage all activities associated with manufacturing engineering and shared services in support of all in-vitro diagnostics products manufactured at Quest. Provide oversight of engineering activities associated with equipment and process validations, improvement projects, packaging designs, technology transfers, and shared services. Lead product development activities in collaboration with Manufacturing and R&D. Design manufacturing processes to improve efficiency, productivity, and quality. Ensure manufacturing processes follow IVDD/IVDR, FDA, and ISO requirements. Supervise team of 1-5 employees. Up to 25% domestic travel required to east coast facilities/offices. 

REQUIREMENTS: Bachelor’s degree (or foreign equivalent) in Engineering (any) or related technical field. Experience must include: 5 years of experience in Manufacturing or Engineering within in-vitro diagnostics (IVD), medical devices, or pharmaceutical industry; IVD manufacturing technologies (reagents/kitting) processes, and systems; ensuring compliance with FDA and ISO requirements for facility services; 3 years of experience in equipment controls and equipment selection and purchasing (bottling, liquid dispense, labeling, printing); and utilizing Lean or SixSigma principles and methodologies for improvement projects.

Salary range $140,774 - $215,700 / year 

To apply, submit CV on careers.questdiagnostics.com using requisition number: 57652