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

   

  Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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