Quality Engineer

Job is on site, in the CQXM – RPA Lab (Complaint returned product analysis lab)

In our Customer Quality Experience Management (CQXM) Returned Good Analysis (RPA) Lab, which is part of the Galway CQXM Complaint Handling and Regulatory Reporting Department. We focus on complaint handling and post market regulatory reporting activities for a wide range of products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.

A Day in The Life Of:

• Ability to work within a team environment and build relationships across the organisation as well as with external suppliers & regulatory agencies etc.
• Co-ordination of complaint handling Analysis and Investigation activities for a wide range of products including receipt and documenting of incoming complaint devices relating to events.
• Perform analysis and investigation, and laboratory duties related to the complaint Analysis and Investigation activities. Assisting in test procedure development and non-routine analyses relating to root cause investigations.
• Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
• Possess an awareness of the manufacturing process and final products, including terminology associated with the product use and failure modes typically experienced by the customer
• Conduct laboratory support functions, Performs and coordinate instrument maintenance, calibration and alignment checks.
• Communicate key information including escalation of Quality Issues to the CQXM Management and key extended post market quality teams & functional management to ensure full engagement &alignment.
• Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the CQXM department. Delivering cost-down through innovative solutions.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• Support new product launch as part of the Product Development Process ensuring that CQXM requirements are included in the process.
• Ensure compliance to all applicable department, site-wide procedures and regulations. Support Internal and External audit preparation and activity which includes application and maintenance of quality standards for all activities associated.
• Train and support new analysts.

Key Skills & Experience 

• Min of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Science)
• Experience in a medical devices or related environment desirable
• Strong interpersonal, communication and organizational skills
• Practical working knowledge of statistical data analysis, problem solving and quality improvement tools and techniques preferable
• Technical writing skills
• Ability to multi-task and to take initiative is essential
• Effective time management skills
• Builds and maintains positive relationships with others; shows respect and consideration for others