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Quality Inspector 1

Req ID: J2278716

  • Ubicación
    West Chester, Pensilvania, United States of America
  • Categoría Grupo de Calidad
  • Publicado jueves, 15 de julio de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

OVERALL RESPONSIBILITIES:   

·         The inspection of in-house and vendor purchased products, raw material and services. 

·         The inspection of packaging and labeling materials used for medical devices. 

·         Performs DHR review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory. 

POSITION DUTIES & RESPONSIBILITIES:   

Inspection Function:  

·         Inspects incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans. 

·         Prepares necessary documentation and ensures paperwork compliance on all inspected items. 

·         Assist in training of co-workers in new or improved techniques in areas of experience. 

·         Assists in identification and segregation of non-conforming materials/products. 

·         Works from inspection documentation, specifications, blue prints, written and verbal instruction. 

·         Performs “Roving Auditor” function involving inspection of product in a Manufacturing Flow Cell. 

·         Performs other related duties as required. 

DHR Review Function:  

·         Performs Device History Review Inspection and final release of product to inventory control/warehouse. 

·         Performs filing and supports the imaging and verification process for Device History Records and other Quality System documentation. 

     Compliance Responsibilities:  

·         Know and follow all laws and policies that apply to one’s job, and maintain the highest levels of professionalism, ethics and compliance at all times. 

·         Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. 

Leadership Responsibilities:  

·         Demonstrates strong initiative 

·         Self-motivated 

·         Exhibits positive attitude 

·         Accountability 

·         Dependability 

·         Cooperative attitude  and inspires teamwork 

·         Leads by example 

·         Requests feedback and utilizes it to improve 

·         Drives cultural change 

EDUCATION AND EXPERIENCE REQUIREMENTS:   

·         High school diploma or equivalent. 

·         ASQ (American Society for Quality) courses desirable. 

·         Zero to one year experience utilizing inspection techniques in Medical device or Pharmaceutical Industry. 

·         Experience with MRP/ERP systems, preferred. 

OTHER REQUIREMENTS:   

·         Ability to read and interpret measuring instruments, including but not limited to:  calipers, micrometers, dial indicators, optical comparators, plug gauges, hardness testers, etc. 

·         Good math skills, color verification and good hand/eye coordination. 

·         Ability to communicate and work with various functional groups in a team environment. 

·         Ability to learn PC applications required. 

·         Lifting weight up to 20 pounds on regular basis and up to 50 pounds on occasional basis. 

·         Must be able to stand for scheduled work hours, if necessary. 

·         High level of concentration and attention to detail required ensuring products are properly labeled and packaged according to internal quality requirements. 

·         Vision in both eyes must be at least 20/30 or correctable to 20/30.  

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