- Reference: GJ3465534
- Job Type: Permanent
- Location: Galway, Galway City, Limerick
- Category: Medical Devices
- To maintain and manage the Quality Management System (QMS) and the Operational Quality Requirements.
- Monitor and continuously improve Vivasure Quality Management System, Product Development Processes and Operational Effectiveness.
- Monitor and continuously evaluate Vivasure QMS against international, regional and local standards/regulations and guidance’s.
- Monitor, support and continuously improve Vivasure 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 Vivasure 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.
- Minimum 6- 8 years experience within Medical Device, Pharmaceutical or IT Industry.
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
For a confidential discussion and more information on the role/company please email your CV to: email@example.com