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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 / marcel@sigmar.ie

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