Quality Assurance Specialist

2 weeks ago

Kilkenny, Kilkenny, Ireland beBeeEngineer Full time €60,000 - €80,000
Engineering Role at a Global Healthcare Leader

We are seeking an experienced professional to play a key role in helping people live more fully at all stages of their lives.

This position is part of our portfolio of life-changing technologies that span the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products, and branded generic medicines.

The new manufacturing facility in Kilkenny will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies.

Main Responsibilities

  • Contribute to the execution of validation activities for ADC assembly lines and facilities.
  • Collaborate with R&D, QA, PMO, and Global Engineering functions to define and document validation strategies for new product introductions.
  • Analyse proposed changes and/or new products to determine the scope of validation work.
  • Develop, execute, and/or review validation protocols and associated reports for related Process & Software Validation Activities.
  • Identify improvements to manufacturing processes and software, and assist with their implementation.
  • Manage multiple responsibilities simultaneously while adhering to project plans and timelines, and report on progress to management.
  • Provide guidance and mentoring to junior engineers as required.
  • Maintain compliance with applicable Corporate and Divisional Policies, and perform other duties as assigned by management.
  • Familiarity with cGMP and industry regulations.

Requirements

  • A relevant third-level qualification in Engineering/Manufacturing/Science is preferred.
  • Minimum 2 years' experience in the Engineering/Manufacturing/Scientific field.
  • 2 years' working knowledge of process, equipment, facilities, and/or software validation either within Quality or Engineering departments.
  • A basic understanding of design controls, design transfer, and validation lifecycle.
  • Experience working in a 21CFR820 and/or ISO13485 regulated industry.

About Us

We are a global healthcare leader that has been making a difference in the lives of people since 1946. We employ over 5,000 people across nine sites in Ireland, with commercial, support operations, and shared services in Dublin and Galway.

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