Quality Engineering Manager - Dublin.
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 Duties and 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.
Interested applicants should have:
• 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.