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Vacancy Details

Engineering & Technical

Senior Quality Engineer - Limerick

Contract Type: Permanent
Location: Limerick
Date: 17/10/2018
Job Reference: 96058

Job Description

Contact: Bimi Felix
Telephone: 086 8395533

Senior Quality Engineer

Our client, a medical device company in Limerick is currently looking to recruit a Senior Quality Engineer for their site.

Job Description
Quality Systems development
  • Begin to develop Quality system to support design activities
  • Provides guidance and Quality oversight to ensure establishment and execution of sustaining programs aligned with regulatory requirements and industry standards.
  • Support new product development activities to ensure work follows proper design control. Ensure controls meet company and FDA regulatory requirements by actively participating on product development.
  • Guides the successful completion of major programs and may function in a project leadership role.

SW Development Guidance – support lab automation activities
  • Help Facilitate Document review and approval with Diagnostic Systems BU.
  • Assist with Test Case Reviews

General Guidance for Project/New Employee Onboarding
  • Accessing C2C training/understanding DS training requirements
  • Accessing SAP
  • Accessing TFS
  • Accessing Sharepoints

Test Instrument Consumables/Reagent Control
  • Create Receiving and material handling SOPs
  • Temperature Records Management (e.g. temp charts, OOS, etc.)
  • OOS SOP/Investigation management

Lab Equipment Controls
  • Calibration/PM – Managing, reviewing/approving/OOS investigations
  • Blue Mountain RAM Access/Management (Data entry)
  • IQ/OQ review/approval
  • Liaison with Field Service Engineers to ensure proper documentation of servicing

Technology Development Understanding/Guidance
  • Help project teams understand process and requirements
  • Help facilitate technology integration (i.e. transfer to GPDS)
  • Provides guidance to team and application of Design Controls 21CFR 820.30 for new product development.
  • Creates and supports documentation.

For further information on this Senior Quality Engineer role in Limerick please contact Bimi Felix on 086 8395533 /

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