Quality Engineering Manager

ICDS RECRUITMENT

DUBLIN NORTH

Quality Engineering Manager, Medical Device- Dublin. Core Purpose: In this role you will be responsible for the management of the manufacturing quality function across the business, and driving compliance and a “Continuous Improvement” culture within the organisation. Core Responsibilities: Establish and develop quality systems, procedures and policies in line with corporate and customer requirements. Lead continuous improvement initiatives to ‘challenge’ the quality systems processes with respect to compliance / value add. Responsible for leading and developing a dedicated team of professionals in order to support the compliant operations within the associated business unit. Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner. Monthly and quarterly reporting of Quality Key Performance Indicators (KPI’s) both internally and to corporate including the coordination of necessary activities to drive improvements or address adverse trends. Drive the achievement of set targets as specified in the ‘Balanced Score Card’ system of continuous improvement. Lead and manage risk assessments across the business to drive quality improvements. Drive improvements via data analysis on product and process and drive best practice across the business. Play a key part in transfer projects to ensure flawless transition into Operations. Provide critical support to the business units with regard to vendor qualifications / corrective & preventative actions. Develop and sustain the drive towards a business unit culture of ‘walk-in’ audit readiness. Play an integral role in planning and managing all activities with respect to quality audits / visits. Execution of Validation Master Plans (VMP) with follow through to Validation Summary Reports. This will also include the sign-off on validation documentation for operational validation activities. Batch paperwork review and final decision to release product for shipment. Drive and embed and preventive action culture via root cause investigation and collaboration with Operations. Interface with other corporate sites with respect to sharing of best practices. Act as a coach and mentor to reporting staff and colleagues. Lead and manage a high performing team to deliver the defined business goals & objectives. Identification and development of talent to include performance management and succession planning. Coaching / development of the employees using development and retention plans as appropriate. Qualifications & Experience: A third level qualification in Engineering/Quality/Science. Must have a thorough understanding of Quality Systems / CFR’s eg. ISO 9001 / ISO 13485 / ISO 14001, 21 CFR Part 21 / 820. Must have a thorough understanding of statistics, SPC, and preferably DOE/Windows studies. Must have a minimum of 7 years' quality management experience, preferably in a high volume FDA regulated environment. Must be able to work in a team environment. Must be able to prioritise and organise tasks. Must have excellent communication skills both oral and written. Ideally will have experience of medical device development from concept to market launch. Ideally 6 Sigma certified “Greenbelt”. Ideally have injection moulding / high speed automation experience.

1420 days ago