Senior Quality Engineer

COLLINS MCNICHOLAS RECRUITMENT

GALWAY

Job Objectives. To maintain and manage the Quality Management System (QMS) and the Operational Quality Requirements. Monitor and continuously improve our clients Quality Management System, Product Development Processes and Operational Effectiveness. Monitor and continuously evaluate our clients QMS against international, regional and local standards/regulations and guidance’s. Main Duties and Responsibilities. Monitor, support and continuously improve our clients Quality Management System, Product Realisation Processes and Operational Effectiveness, with particular emphasis on CAPA, Calibration, Problem Solving, Design Review, Risk Management, Supplier Management, Auditing, Non-conforming materials disposition, Process Support, Incoming Inspections, In-Process Inspections and Process Validation. Liaise with external parties in relation to matters pertaining to our clients Product Realisation Process execution and QMS effectiveness. Actively support the Document Control System including incorporation of outsourced activities. Generation of Protocols, Reports, Work Instructions, Forms and Procedures. This is to support process development, operational effectiveness, the product realisation process and the QMS. Examples Include (but not limited to): Prepare executive documentation e.g. management review minutes, design review minutes, internal audit summaries, metrics updates. Conduct internal quality system audits as well as audits of external suppliers/subcontractors in compliance with applicable regulatory and QMS requirements. Support the documentation and management and delivery of Training. Support the development, writing and compiling of the Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions for Notified Bodies, FDA and Competent Authorities where necessary. Support the creation of work instructions and test instructions. Support creation of (and auditing of) Bill of Materials, Device History Records, etc. Expedite processing and sign-offs of documents and DCNs. Work Experience or Training Required. Degree qualified in related technical discipline. Minimum 6 years experience within the Medical Device or Pharmaceutical Industry. Experience and understanding of regulations related to medical devices e.g. ISO 13485, MDD, and applicable FDA Requirements. Experience in writing documentation in a regulated environment. Experience in conducting audits in a regulated environment. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1660 days ago