Quality Operations Engineer. Cork. €25~€32 per hour.  

Quality Operations Engineer. Cork. €25~€32 per hour.  

Initial 12-month contract. Onsite role.  

Reporting to the Quality Operations Team Lead.  

This person will be working across two departments in calibration/ stores receiving area. 

Position Overview 

The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations. They coordinate phases of work internally and externally. The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.  

Responsibilities & Duties 

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. 
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs. 
• Review/analyze whether current product and processes (including actions or decisions conducted) comply to standards such as the QSRs, ISO 13485, etc. 
• Conduct periodic line audits to assess for production controls such as lot segregation.  
• Review results of area audits to ensure that corrective and preventive actions are adequate. 

• Supports new product introduction as part of design transfer. 
• Conduct investigation, bounding, documentation, review and approval of non–conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate. 
• Review root cause investigation according to an established process. 
• Approve IQ, OQ, PQ, TMV or Software Validation, Production/Process Controls including Control Plans 
• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs 
• Ensures effective quality strategies are created for the validation of test methods, process and design. 

Qualifications 

• A minimum of a level 8 Bachelor’s Degree, preferably in Engineering or related technical field.  
• Requires 1-2 years related experience. 
• Experience working in both an FDA and European regulatory environment is preferred. 
• This position will require relevant experience working in manufacturing/operations. 
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. 
• Experience with a proven track record of implementing appropriate risk mitigation. 
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.