Quality Systems Manager – Galway city | Collins McNicholas

Quality Systems Manager – Galway city

  • Reference: GJ3465534
  • Job Type: Permanent
  • Location: Galway, Galway City, Limerick
  • Category: Medical Devices

Requirements:

  • To maintain and manage the Quality Management System (QMS) and the Operational Quality Requirements.
  • Monitor and continuously improve Vivasure Quality Management System, Product Development Processes and Operational Effectiveness.
  • Monitor and continuously evaluate Vivasure QMS against international, regional and local standards/regulations and guidance’s.
  • Monitor, support and continuously improve Vivasure Quality Management System, Product Realisation Processes and Operational Effectiveness, with particular emphasis on CAPA , Calibration, Problem Solving, Design Review, Risk Management, Supplier Management, Auditing, Non-conforming materials disposition, Process Support, Incoming Inspections, In-Process Inspections and Process Validation.
  • Liaise with external parties in relation to matters pertaining to Vivasure Product Realisation Process execution and QMS effectiveness.
  • Actively support the Document Control System including incorporation of outsourced activities
  • Generation of Protocols, Reports, Work Instructions, Forms and Procedures. This is to support process development, operational effectiveness, the product realisation process and the QMS.
  • Minimum 6- 8 years experience within Medical Device, Pharmaceutical or IT Industry.
  • Examples Include (but not limited to):

    • Prepare executive documentation e.g. management review minutes, design review minutes, internal audit summaries, metrics updates.
    • Conduct internal quality system audits as well as audits of external suppliers/subcontractors in compliance with applicable regulatory and QMS requirements.
    • Support the documentation and management and delivery of Training.
    • Support the development,  writing and compiling of the Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions for Notified Bodies, FDA and Competent Authorities where necessary

    • For a confidential discussion and more information on the role/company please email your CV to: christopher.otoole@collinsmcnicholas.ie


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Christopher O'Toole

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  • Christopher O'Toole
  • Senior Recruitment Consultant
  • 091 706713
  • Connect with Christopher

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