Engineering Specialist

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• 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

Qualifications: 

• 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