Quality Engineer

Quality Engineer

Job Title: Quality Engineer
Contract Type: Permanent
Location: Dublin
Salary: €40000 - €50000 per annum
Start Date: ASAP
Reference: HQ00050736
Contact Name: Rachel Radford
Contact Email:
Job Published: January 23, 2017 13:43

Job Description

Your responsibilities will include but not be limited to:

  • Manage direct reports including: develop and retain talent; establish and maintain clear roles and responsibilities; ensure adequate resource utilization.
  • Support the maintenance of an effective Quality Management System that complies with international standards and relevant regulatory requirements
  • Understand new regulations and guidelines, and implement systems and procedures to incorporate these new regulations.
  • Establish, track and respond to leading and lagging Quality Key Performance Indicators (KPIs).
  • Provide Quality Engineering and Statistician contributions to cross-functional project teams that develop and/or transfer new diagnostic products under Design Control processes.
  • Provide Quality Engineering and Statistician contributions for the approval and implementation of Design Changes to existing products and processes.
  • Provide Quality Engineering and Statistician contributions and approval for product stability/monitoring programs.
  • Provide Quality Engineering and Statistician leadership to CAPA and other investigations; maintain and develop functional expertise in: product and process technology, investigations, Root Cause Analysis, report writing, statistical data analysis, and implementation of actions arising from CAPA processes.
  • Responsible to ensure that all released products meet the release testing processes, criteria and specifications. Responsible to understand how the release specifications trace to the product Design History File.
  • Track and trend quality control and release testing data for all product lines; statistical process control engineering; trend alerts; Cp and CpK metrics.

International travel (up to 20%) may be required.

Qualifications / Experience

  • Primary degree qualification in a science, engineering or business discipline.
  • Minimum 6 year experience in in vitro diagnostics or related industry.
  • Design control and design transfer
  • Process engineering
  • CAPA and other investigations involving root cause analyses
  • Successful implementation of continuous improvements to QMS
  • Project management of change programs
  • Building and leading effective teams, and highly motivated individuals
  • Skills and Behaviours
  • Excellent verbal and written communication skills.
  • In-depth knowledge of International Standards, GLP and GMP.
  • Ability to successfully implement change.
  • Ability to manage complex projects involving multiple functions.
  • Strong technical and analytical/problem-solving skills
  • Ability to collaborate with and influence groups in a positive, team‑based environment

If you are intereste in this role please don't hesitate to apply!

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