Descripción del Empleo:
Description: Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Writes procedures, protocols and any other documentation needed for the implementation or enhancement of systems or equipment.
•Provides coaching to the manufacturing team on tools for process, monitoring enhancement, procedures and equipment, analytical troubleshooting, FMEA/ PPM/ MVR development, statistical concept application, and QSR/ISO requirements. Drives implementation of these tools.
• Initiates, reports, and recommends special studies and qualification of new products.
• Reviews and approves qualification / validation
Background • Educational: Applied or Natural Science, Engineering or Science of Engineering (Mechanical, Electrical, Chemical) or field related to previously mentioned background. 2 years of relevant experience, or advanced degree with 0 years of experience.
• Related experience (COOP/Internship) in medical device or pharmaceutical.
• Robotics or Automaton Principles Training
• Cleaning Validation Principles Training
• Technical Writing
• Validation Training
• Fluency speaking and writing in English and Spanish