Quality Engineer II (Quality Systems Group)

My client develops and manufactures medical devices used by interventional cardiologists, radiologists, and vascular surgeons in angioplasty procedures. This organisation is going through massive growth currently and they are looking for Quality Engineers to join their team on both a permanent and a 1 year fixed term contract basis. This role will be part of the Quality Systems group of the organisation.

The Position:

In your capacity as Quality Engineer, you will lead risk management and qualification activities (IQ/OQ/PQ/TMV/CQ) in conjunction with project teams as well a heading up the Quality Engineering activities for New Product Development (NPD) projects, supporting and participating in NPD teams. You will also:

  • Review and approve all design file output from NPD projects
  • Identify quality systems engineering improvement opportunities and execute through the change management system
  • Participate in internal audit and supplier audit programmes

The Person:

The ideal Quality Engineer must have a level 8 technical degree with a high level of documentation experience. You will also have 3 years’ experience in Medical device or Pharmaceutical industry with auditor experience. Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR are important for the successful execution of this role.

The Benefits:

  • Salary up to €50k depending on experience
  • Bonus
  • Education assistance
  • VHI Healthcare
  • Pension

For more information on this role, apply now or call Chris Dennehy at HRM on +353 21 4511195

Salary: €40000 - €50000 Location: Wexford