DescripciónDescription
Designs and plans layout for activities such as machining, metal forming, plastics processing, welding and brazing, assembly, and materials handling. Adapts machine or equipment design to factory and production conditions. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. May incorporate inspection and test requirements into the production plan. 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. Complies with company programs, procedures and applicable quality system regulations and standards.
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Requisitos Requirements
Preferred Qualifications:
- Process Development and documentation
- Equipment validation
- SOP Development
- Line layout and infrastructure and development
- MES (Manufacturing Execution System)
- Special Build Documentation and Line Support
Top Qualifications:
- 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)
Other Skills
Computer and software validation CSV
SOP Development
Change control of Medical Devices
MES system
Bachelor of Science in Engineering with 3 to 5 years of experience in Medical Device Industry preferred
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Requiere Mucha Experiencia
Requires Expert
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BeneficiosBenefits Package
W2 Temp Employee
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Empleos en Puerto RicoJobs in Puerto Rico
Professional Pharma Solutions
Empleos en Puerto RicoJobs in Puerto RicoIngenieros
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