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Job

Validation Engineer

  • Job ref:

    11178

  • Location:

    Manchester, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    9 months ago

  • Consultant:

    #

Validation Engineer

 

 

Responsibilities:

  • Work collaboratively with operations team to develop manufacturing processes that consistently meet all product requirements
  • Ensure all product, processes, and components are within specifications and work with internal team and with customers to resolve any non-conformance issues
  • Develop Validation protocols and sampling plans according to the risk level of the components, material and devices
  • Lead Validation execution, documentation and author reports
  • Review existing inspection procedures and sampling plans for continuous improvement and improved workflow
  • Provide guidance and assistance on manufacturing processes for new and existing manufacturing lines
  • Review Device History Record process and ensure tracking and configuration is maintained prior to shipment
  • Participate in Material Review Board (MRB) meetings and follow through with non-conformance issues
  • Participate in ISO 13485 audits and assist in FDA and other regulatory inspections

Requirements:

  • Candidate must have a B.A or B.S. in relevant technical field
  • At least 3 years’ experience and/or training in Medical Device field is preferred
  • Knowledge of IQ/OQ/PQ requirements
  • Knowledge of component forming processes, assembly processes, and production line optimization
  • Strong understanding and prior successful implementation of Lean Manufacturing Principles
  • QSR Part 820 and ISO 13485 experience
  • Strong communication and time management skills