Our client, a global healthcare manufacturer, is seeking a Quality Engineer to join their operations in Dublin. The candidate will report to the Quality Engineering Manager in and will be responsible for the management and execution of process validation studies, active participation in non-conformance investigations, process improvement projects, project management, application of SPC to current production processes and liaising with key customers.
• Be a key driver of cGMP practices within Operations and Quality Divisions
• Responsible for providing support for the ISO9001/2000 and ISO 13485 and 21CFR Part 820 Quality Systems
• Responsible for ensuring adherence to all BD and external regulatory requirements
• Responsible for becoming an active member of the site internal audit team, liaising with Regulatory auditors.
• Preparing and maintaining documentation in compliance with the appropriate regulatory requirements
• Support production personnel in relevant continuos activities (Six Sigma etc.)
• Acting as a consumer liaison contact for given key customers as appropriate
• Review, analyse and report on relevant customer complaints
• Degree in Science/Engineering discipline (Polymer Science/Engineering or Mechanical Engineering preferable)
• Minimum of 5 years experience in an ISO 9001/2000 or ISO 13485 environment, coupled with a background in Medical Devices/Pharmaceutical Industry.
• Experience in the preparation of Technical Documentation
• Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
• Experience in CAPA system management
• A working knowledge of FDA requirements and managing FDA audits.
• Experience in process validation and working in a clean room environment.
• Proven ability of working in a cross-functional team environment.
• Excellent interpersonal and communication skills and high level of computer literacy.
If you would like further Information you can contact the recruiter directly:
Oran McIvor | Tel: +353 (0) 1 507 9270