Quality Engineer - Waterford
Reporting to the Quality lead, the successful candidate will be liaising with Engineering, Production and other Departments in maintaining the Quality Systems in compliance with ISO13485 and AS9100 requirements. You will also work closely with Medical QC, Production and Engineering personnel to ensure product quality during the production process and also finished product tests prior to dispatch to the customer are being completed correctly and successfully.
- Responsible for the cleanroom facility management including HVAC and supportive utilities within a GMP compliant Quality Management System.
- Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.
- Participate in risk assessments, inspections, audits, incident investigations and implement and follow-up related CAPA's as required.
- 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 such as CAPA, 8D, A3 Problem Solving.
- Honours Degree in Mechanical/Manufacturing/Production engineering or similar.
- Knowledge of cleanroom environmental monitoring.
- ISO 9001-13485 CFR 820 Knowledge essential.
- Experience in working with quality tools and knowing when to implement them across teams.
- Experienced in Clean Room assembly.
- Experience using six sigma desirable but not essential.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.