Our client a Dublin based Medical Deviceorganization, are currently seeking a Quality Manager to join their team. Reporting to the Head of Quality and Regulatory Affairs the Quality Manager will lead, manage and grow a team, be required to liaise with regulatory notified bodies and can operate within a small company environment


Role/Responsibilities:

• Responsible for the implementation and maintenance of the Quality Management System in line with applicable regulatory requirements including EN ISO 13485:2016, MDD 93/42/EEC, MDR 2017/745 and FDA 21 CFR820
• Manage and mentor direct report/s
• Assist in the CE marking of new and approved devices and potential FDA approvals
• Responsible for production batch release
• Manage the Complaints System and drive complaint investigations to ensure complaints are closed out in a thorough and timely fashion
• Manage the CAPA System and drive CAPA investigations to ensure CAPA’s are closed out in a thorough and timely fashion
• Manage the Internal Audit System to ensure audits are performed on time and that associated non conformances are closed out in a timely fashion. Perform internal audits as required
• Manage the activities associated with Vendor Qualification and ongoing monitoring of such. Performance of Vendor Audits and timely resolution of vendor issues
• Management of the Documentation Change Control System
• Oversight and management of the Validation and Requalification schedules on-site
• Management of the Management Review process including scheduling, compilation of data and presenting such data at the Management Review Meetings. Document associated minutes and ensure thorough and timely closure of associated action items
• Manage the coordination of activities in preparation for and during external audits such as regulatory audits and customer audits and assist with the hosting of such audits as required
• Manage the Continual Improvement Process on site including the annual review and assignment of site KPI’s and Quality Objectives. Collate and report on such on a monthly basis
• Manage and present monthly Quality Update/KPI Trend Meetings
• Manage the Deviation System
• Coordinate Risk Management activities in line with EN ISO 14971
• Provide Quality Training as needed including annual GMP training and induction training
• Ensure all Quality-related projects are completed according to agreed deadlines and timescales
• Perform additional duties as required within the role of Quality Manager as directed by the Head of Quality and Regulatory Affairs

• Educated to Degree level in a Science (Chemistry, Microbiology or Quality Assurance) or Engineering discipline
• A minimum of 5-7 years experience working in a Senior Quality Role in a Medical Device Environment with CE approved products
• Experience in managing and working with medical device regulations and standards including EN ISO 13485:2016, EN ISO 14971, MDD 93/42/EEC, MDR 2017/745 and FDA 21CFR820
• Previous people management experience
• Qualified internal auditor trained to Lead Auditor level
• Excellent cross-functional communication skills and attention to detail
• Excellent written, organizational and computer skills
• Ability to work with cross functional teams on multiple projects in a fast-paced environment
• Self-motivated with the ability to deliver independently