Qualification Tech

MISSISSAUGA, ON , CANADA

Description

Excelitas Technologies is a global technology leader focused on delivering innovative, high-performance, market-driven photonic solutions to meet the illumination, optronics, detection and optical technology needs of global customers. Serving a vast array of applications across biomedical, scientific, safety, security, consumer products, semiconductor, industrial manufacturing, defense and aerospace sectors, we stand committed to enabling our customers' success in their end-markets. Globally we employ over 6,700 people across sites in North America, Asia and Europe.

 

As manufacturers of the future, we push the limits of what is technologically possible, through international collaboration, trusted experience and a sense of purpose. At Excelitas Technologies YOU are how we Excel.

 

We are presently seeking a Qualification Technologist who will be responsible to write and review qualification documentation, such as IQ, OQ, PQ documents and to provide support to Manufacturing Engineers with New Product Introduction (NPI) tasks and released product support.

 

Your Responsibilities:

  • Write and execute Installation/Operation and Process qualification documents (IQ, OQ, PQ) compliant to ISO13485 and site policies and procedures.
  • Proactively identify risks and potential manufacturing issues and support Manufacturing Engineers with Process Failure Mode and Effects analysis (pFMEA).
  • First point of contact for production support.
  • Assist Manufacturing Engineers with the development and improvement of manufacturing methods for new and existing product.
  • Update manufacturing and test documentation as required.
  • Prepare Deviations, Change Orders and Work Instructions as required to support changes and updates.
  • Support Manufacturing Engineers with designing and developing tools, fixtures and jigs to aid in assembly and test including wiring, assembly and soldering.
  • Assists Manufacturing Engineers and Production Technicians with NPI Beta and PPR builds.
  • Provide training to production staff on internal manufacturing and test procedures (MAPs / ITPs) and work instructions for Dispositions for Non-Conforming Product or Change Order.
  • Assist Manufacturing Engineering Team to setup work benches and test stations as necessary to prepare the work center for production use.
  • Verify the integrity of work order components and assembly instructions.
  • Assist in providing estimates for production times and number of operators required based on cycle times.
  • Support Manufacturing Engineering Team to resolve issues with production fallout and First Pass Yield (FPY) to determine root cause and suggest and implement solutions to reduce loses and improve efficiency.
  • Support Quality Assurance (Q.A.) to execute procedures for test and inspection of components that require sophisticated levels of inspection.
  • Support production and service staff with troubleshooting systemic or challenging issues.
  • Participate in continuous improvement projects to improve design and manufacturing throughout the product lifecycle.
  • Other duties as assigned.

Your Requirements:

  • 3-5 years’ experience in Manufacturing Engineering in a manufacturing/production environment.
  • Engineering Degree in a related discipline and/or C.E.T.
  • Experience in writing, execution and reviewing IQ,OP,PQ.
  • Practical experience in electro-mechanical final assembly.
  • Experience in building and assembling electronic Printed Circuit Board (PCB) and functional test jigs
  • Experience working with Product Life Management (PLM) software.
  • Experience working with a MRP system preferably QAD.
  • Experience with production final acceptance testing.
  • Advanced computer skills
  • Excellent communication skills, verbal and written.
  • Ability to work with a diverse workforce, in a team environment.
  • Must be familiar with RoHS, WEEE, ISO9000, ISO13485 (IQ, OQ, PQ), Lean Manufacturing, 5S and general product safety requirements such as CSA, UL, TUV.
  • Must work well within rapid product development and launch processes, with full appreciation for the product design process and manufacturing processes currently in place.
  • Experience working in an ISO9001, 14001, 13485 certified, and/or FDA QSR compliant environment is an asset.

To join our team of experts, please visit the career section of our website at www.excelitas.com for more information.

Requirements
We are seeking a Qualification Technologist who will be responsible to write and review qualification documentation, such as IQ, OQ, PQ documents and to provide support to Manufacturing Engineers with New Product Introduction (NPI) tasks and released product support.
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