Staff Manufacturing Engineer
About The Position
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.
- 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)
- Utilizing Lean or SixSigma principles and methodologies for improvement projects
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
