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Validation Engineer

Katalyst Healthcares & Life Sciences

  • Boxborough, MA
  • 24 days ago

    Highlights

    The code for the testers will be written by an internal resources with whom this person would work closely in order to complete the paperwork and qualify the systems. Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.

    Numbers & Facts

    LocationBoxborough, MA

    Description

    Roles & Responsibilities :
    • Test Stand & LabView experience along with some Manufacturing equipment validations (IQ/OQ /PQ) experience
    • Test Engineer that can help qualify Automated Functional Testers.
    • Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.
    • The code for the testers will be written by an internal resources with whom Candidate would work closely in order to complete the paperwork and qualify the systems.
    • Candidate may also help assemble the hardware side of the tester.
    • Good To have - Background in Test Stand | LabView that would be a bonus to help debug and trace requirements.
    • Qualify automated functional test systems and support troubleshooting.
    • Develop and maintain validation documentation| including requirements| trace matrices| test protocols| and reports.
    • Execute verification and validation testing| document results| and manage deviations.
    • Ensure compliance with internal quality systems and regulatory standards.
    • Collaborate with cross functional teams to support product testing and continuous improvement.
    Requirements:
    • Bachelors degree in Engineering or related discipline.
    • Experience in verification validation testing| preferably in medical devices or other regulated industries.
    • Familiarity with automated test systems and documentation best practices.
    • Strong analytical| documentation| and problem solving skills.
    • About Client Medical device customer USP of the Role and Project
    • Would be responsible for writing all the documentation (requirement| trace matrix| protocols| reports using this.
    • The code for the testers will be written by an internal resources with whom this person would work closely in order to complete the paperwork and qualify the systems.
    • They may also help assemble the hardware side of the tester.
    • Candidate should have experience as tester development for Manufacturing
    • Candidate should have experience with the validations within the MFG environment - IQ| OQ| PQ
    • Responsible for writing all the documentation (requirement| trace matrix| protocols| reports using the Healthcare templates) and executing the validations.
    • If they have background in Test Stand LabView that would be a bonus to help debug and trace requirements.
    • Essential Skills: Functional Testing
    • Skills: Functional Testing
    • Skills: MFG/PRO Domain (QAD)
    • Experience Required: 4-6

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