Quality Engineer (Cleanroom)

Job description

One of the world's leading medical devices companies is looking for an experienced Quality Engineer (Cleanroom) to join their Waterford team on a permanent basis.

Job responsibilities:

  • Responsible for the cleanroom facility management (qualification/maintenance/ extensions) .

  • Supporting NPI team in the execution of Performance Qualification (PQ) .

  • Periodic Review and Revalidation activities for clean utilities, systems and equipment.

  • Maintaining and implementing environmental controls.

  • Supporting deviation investigations throughout the facility.

  • Serving as a subject-matter expert on validation activities during regulatory agency inspections

  • Participating in risk assessments, inspections, audits, incident investigations, etc. 

  • SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques)

  • Evaluating materials, gathering and analysing data and determining root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving).

Job requirements:

  • Level 8 Degree in Engineering or similar

  • Knowledge of cleanroom environmental monitoring & Regulatory requirements

  • 5+ years' experience in GMP environment

  • ISO 9001-13485 & CFR 820 Knowledge

  • Excellent customer contact, negotiation and problem resolution skills.

  • Able to independently work with quality tools and knowing when to implement them across teams, RC, Brainstorming, 5Why, Fishbone, CAPA, NC, NCMR, 8D, A3, SIPOC, Process Maps, Heat Maps.

  • Clean Room assembly experience

For a confidential discussion on this or any other current job opportunity please contact Marcel Skolimowski on 021 4847 138 /

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.