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.
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).
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 / email@example.com
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