This innovative medical devices organisation has been enhancing medical diagnosis for over 20 years, developing a broad spectrum of immunoassays, chemistry, haematology, molecular urinalysis and blood gas testing systems. A pioneer in it's field, this business invests heavily in technology to enhance medical diagnosis. An opportunity has recently become available for a strong QA professional to lead a developed Quality team based at their their state of the art manufacturing plant in Dublin, which is currently seeing and undergoing expansion as a result of product being introduced to the site.

The Position:

• Leading, Directing, Managing and Coordinating the Quality Assurance activities onsite supporting the manufacture of large medical devices/diagnostics. Achieving and sustaining a focus on and commitment to Quality in the manufacture of our products and services. Driving process measurement initiatives, including scorecards and other metrics, which can also be used to drive process improvements.
• Managing a team of Quality Assurance professionals acting as an SME and Technical expert within areas of responsibility. Lead, mentor and develop the team in deploying, managing and improving processes.
• Strong Customer focus to understand customer requirements appropriately to meet customer expectations and to identify relevant KPIs for quality oversight. Regular customer integration should be fostered with consequent usage of feedback tools, as well as professional feedback. Focus on compliant handling to achieve high customer satisfaction and retention. Clear escalation with fast complaint routing and consequent root cause analysis to satisfy the customer.
• Collaborating with the production and engineering teams onsite for Quality Assurance related activities, initiating continuous improvement in order to consistently fulfill the expectations and needs of customers. Using multiple Data sources and Trend analysis, with the intent to identify design and manufacturing weaknesses for resolution.
• Supporting the Team's Quality Assurance approach across all plant operations. Creating and ensuring value-streams comply with QMS requirements and production targets.
• Supporting QMS and Regulatory Compliance in identifying and responding to Quality problems in the production of Commercial Devices.
• Providing leadership in New Product and Process Introductions in areas such as initial manufacturing Validation and Product/ Process Stabilization. Focus Quality Assurance as a competitive advantage for the site and for the business. Maintaining an appropriate balance between regulatory requirements and business needs.
• Responsible for the management of the Calibration and Preventative Maintenance of Manufacturing Support Equipment onsite. Responsible for quality aspects relating to Validated processes supporting the manufacturing processes onsite.
• Support the embedding of Quality into processes and projects. Ensure implementation and control of quality gates. Preventive quality tools to gain a sustainable higher quality in processes and projects. Initiate continuous improvement with employee participation/ contribution. This requires personal involvement in processes/ projects.

The Person:

• Minimum 5 years' experience in a management or leadership role within a regulated environment. Excellent people leadership, communication and coaching skills. Experience of objective setting, process improvement techniques and a core appreciation of FDA/ ISO standards and regulations.
• Understanding of Manufacturing processes in a high complexity/ low volume environment. To include systems used in production such as 6 Sigma, Lean Principles and Risk management tools. Understanding of validation, quality control testing, CAPA system, document control system(s) and complaint handling systems.

To learn more about this role apply online or contact Shane Browne on + 353 1 6321865 for a confidential discussion.