Ref No: AM17509
County Dublin, Republic of Ireland
Senior Quality Engineer (Design Assurance) - West Dublin.
Reporting to the Design & Quality Assurance Manager, this role will support proprietary design & development projects with key focus and responsibility around the interpretation, application of and compliance to FDA Code of Federal Regulations Part 820, EU Medical Device Regulation 2017/745, ISO 13485 Clause 7.3 and internal procedures. In this role you will manage the quality aspects of proprietary design & development projects; you will provide proprietary design & development teams with guidance on design quality-related issues and design control best practice; and drive a culture of compliance and continuous improvement within proprietary design & development teams.
Core Duties and Responsibilities:
• Program Activities:
o Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; international standards; and enterprise and local procedures.
o Report on the progress of projects; identify successes; and drive compliance.
o Escalate quality-related issues to the Design & Quality Assurance Manager, as required.
o Review and approve relevant design history file documents; device drawings; device specifications; procedures.
• Risk Management Activities:
o Responsible for generating the Risk Management Plan and Risk Management Summary Report on proprietary design & development projects.
o Facilitate risk assessment meetings with proprietary design & development teams.
o Facilitate project risk register meetings and ensure these risk registers are maintained and updated by the relevant program manager or designee.
• Validation Activities:
o Review and approve validation documents (protocols & technical reports).
o Facilitate and support the completion of the pre-PQ checklist.
• Metrology Activities:
o Review metrology data and report to the design & development teams during OQ & PQ.
o Support Quality Function Deployment activities (QFD).
• QMS Activities:
o Drive the closure of change controls and protocol deviations.
o Review and draft relevant procedures and forms for the management of activities connected with product design & development.
o Perform first article component and products inspections
o Draft defect libraries and QSS documents during OQ; and manage formal handover of same to Operational Quality prior to PQ.
o Support the supplier selection process in accordance with supplier management procedures.
o Conduct internal and supplier audits
o Support in the preparation and hosting of third party and customer audits.
• Compliance to all enterprise and local company policies and procedures.
Interested applicants should have:
• Degree in a relevant Science, Engineering or Quality discipline with at least 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.
Ideally you will also have:
• Ideally will have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
• Working knowledge of EU MDR 2017/745, ISO 13485, ISO 14971 and 21 CFR Part 820.
• Working knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
• Risk Management experience within design and development with a good working knowledge of ISO 14971.
• An excellent understanding of plastic process manufacturing, computer systems validation, analytical methods and testing and documentation systems.
• Knowledge of analytical tools and methods, including statistics (Minitab preferred).