Engineering Specialist
Quality Consulting Group
- Villalba, PR
- Temporal
- Tiempo completo
- Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Adapts machine or equipment design to factory and production conditions.
- Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
- Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
- Ensures processes and procedures are in compliance with regulations.
- Work on the introduction on a new product.
- Change control of Medical Devices
- Bachelor Degree in Engineering
- Three (3) or more years of experience
- Experience in equipment IQ
- Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
- Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
- Preferred experience in DOE (with minitab)
- Computer and software validation CSV
- SOP Development
- MES system
- Ability to use statistical techniques to analyze data
- Medical Devices Experience
- Special Build Documentation and Line Support
- Line layout and infrastructure and development
- Process Development and documentation
- Availability for 1st shift