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Quality Inspector 1

Req ID: J2270531

  • Ubicación
    Elmira, NY, Nueva York, United States of America
  • Categoría Grupo de Calidad
  • Publicado miércoles, 5 de mayo 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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