Ref No: AM17189
Waterford, Co. Waterford, Ireland
Quality Engineer (cleanroom) - County Waterford.
You will work closely with QC, Production and Engineering personnel in carrying out scheduled and random checks on product quality during the production process and also finished product tests prior to dispatch to the customer. The Cleanroom Quality Engineer will also be involved with conducting investigations into non-conformances and customer complaints, performing internal audits, preparing SOP’s and templates, assisting in validations, and troubleshooting quality issues.
In this role you will be responsible for:
• Responsible for the cleanroom facility management (qualification/maintenance/ extensions) including HVAC and supportive utilities within a GMP compliant Quality Management System
• Support NPI team in the execution of Performance Qualification (PQ) for cleanroom processes as per the project schedule
• Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.
• Maintain and implement environmental controls
• Support deviation investigations throughout the facility
• Serve as a subject-matter expert on validation activities during regulatory agency inspections
• Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA’s as required
• Create concise and accurate on-time technical reports. Clearly communicate 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)
• Act as the customer conduit for all quality related issues, capable of articulating complex technical solutions to customers in a manner that’s easily understood.
• Create and evaluate metrics to drive tangible quality improvement.
• Evaluate materials, gather and analyse data and determine root cause of problems using relevant corrective action systems (e.g. CAPA / 8D / A3 Problem Solving)
• Manage several projects simultaneously and coordinate multiple, changing deadlines.
Interested applicants should have:
• Honours (level 8) Degree in Mechanical/Manufacturing/Production engineering or similar
• Knowledge of Regulatory requirements
• Knowledge of cleanroom environmental monitoring
• At least 5 years’ experience in a production environment
• At least 5 years’ experience in a quality department
• Customer Complaints Management experience
• GMP experience
• ISO 9001-13485 CFR 820 knowledge essential
• Exposure to SPC and validations
• Understanding of design and the ability to assess concepts with a risk based approach
• 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).
• Cleanroom assembly experience.