Cleanroom Quality Engineer - Waterford
Hartley People
Waterford
We ae currently looking for an experienced Cleanroom Quality Engineer to join our Client’s team and help ensure maintaining the Quality Systems in compliance with ISO13485 and AS9100 requirements. Responsibilities: Cleanroom facility management (qualification/maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management System. Supporting NPI team in the execution of Performance Qualification (PQ) for clean room processes as per the project schedule. Planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment. Maintain and implement environmental controls. Participation in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA’s as required. Communicating results internally and to customer through the use of quality tools and statistical techniques. SME for appropriate statistical techniques to monitor process performance (e.g. SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques. Creating and evaluating metrics to drive tangible quality improvement. Evaluating materials, gather and analyse data and determine root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving. Requirements: Honours (level 8) Degree in Mechanical/Manufacturing/Production Engineering or similar. 5+ years of experience in Quality in a GMP regulated, cleanroom production environment; experience in precision engineering would be favourable. Knowledge of Regulatory requirements (ISO 9001-13485 CFR 820 essential; knowledge of ISO 31000 & ISO14644 desirable. Experience in SPC and validations. 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. Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations would be an advantage. Experience using 6 sigma. Interested? Call Greg on Hartley People’s office number 051 878 813 or email your CV in response to this job posting. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. Hartley People also recruit for similar roles such as QA Technician / Specialist, QA Engineer / Manager, QC Technician / Specialist, Regulatory Affairs Specialist / Manager, Validation Engineer, Process Technician / Engineer, CSV Engineer, IT Support Engineer (all levels), Full-stack Developer, IT Systems Integration Engineer, Business Systems Analyst.
1350 days ago