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Quality Technician - Inspection/DHR

Req ID: J2290026

  • Ubicación
    West Chester, Pensilvania, United States of America
  • Categoría Grupo de Calidad
  • Publicado miércoles, 6 de octubre de 2021
  • Tipo Tiempo completo
  • Tipo de Empleo Empleado Permanente

Descripción del Trabajo

JOB TITLE: Quality Technician – Inspection and DHR

JOB PROFILE: QUALITY TECHNICIAN II (Site Quality Family) 

Level S05 (IL)

OVERALL RESPONSIBILITIES:   

  • Assist with the establishment and implementation of standard processes and improvements that ensure quality targets are achieved or exceeded.
  • Provide day to day operational support to supervisor for Inspection and DHR areas

POSITION DUTIES & RESPONSIBILITIES:   

  • Operational
    • Provide day to day support by managing resources, business priorities, and quality non-conformances
    • Assist in collecting and providing performance metrics and analysis for the department
    • Serves as backup inspector: Inspects incoming, in process and finished products and material for visual, mechanical, and dimensional characteristics, using inspection sheets and applicable sampling plans
    • Serves as backup DHR reviewer: Performs DHR review and “Release to Branch Plant” function including document verification and recording incoming inspection inventory
  • Management
    • Lead training and certification process for new employees and existing employees on new pieces of equipment
    • Manage “Roving auditor” program involving inspection of product in manufacturing cells
    • Manage DHR certification process and interacts with JJMD to maintain this process
    • Performs filing and manages the imaging and verification processes for Device History Records
  • Improvement
    • Assess business performance, analyze business processes, evaluate gaps, identify process improvements, and recommend business solutions
    • Assist in executing projects that increase process efficiencies, reduce cycle time, cost, and improve overall quality of execution
    • Design, organize and implement continuous improvement projects pertaining to inspection, final release and product flow

LEADERSHIP COMPETENCIES:

  • Ability to handle multiple priorities in a consistent and effective manner  in fast-paced environment.
  • Ability to navigate “gray areas” and make informed quality decisions
  • Cooperative attitude and team building skills
  • Desire to work with multifunctional teams (production, quality engineering) to ensure successful operational outcomes

EDUCATION AND EXPERIENCE REQUIREMENTS:   

  • High school diploma or equivalent. 
  • ASQ (American Society for Quality) courses desirable. 
  • Minimum of five years of experience utilizing inspection techniques in Medical device or Pharmaceutical Industry. 
  • Experience with MRP/ERP systems, preferred. 

OTHER REQUIREMENTS:   

  • Strong GMP background and knowledge of appropriate FDA regulations desirable, with medical device experience preferred.
  • Strong verbal and written communication skills required.
  • Microsoft Office (Word, Excel, etc.) skills required.
  • Vision in both eyes must be at least 20/30 or correctable to 20/30 and capable of color verification. 
  • Ability to read and interpret measuring instruments, including but not limited to:  calipers, micrometers, dial indicators, optical comparators, plug gauges, hardness testers, etc. 
  • Lifting weight up to 20 pounds on regular basis and up to 50 pounds on occasional basis. 
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