Our multinational client in South Dublin requires a Quality Engineer. Reporting to the Senior Quality Engineer duties will include management and execution of process validation studies, active participation in non-conformance investigation, process improvement projects, project management, application of SPC to current production processes and liaison with key customers.
• Be a key driver of cGMP practices within Operations and Quality divisions
• Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems
• Become an active member of the site internal audit team, liaising with Regulatory auditors
• Prepare and maintain documentation in compliance with the appropriate regulatory requirements
• Support production personnel in relevant continuous improvement activities (Six Sigma etc.)
• Act as customer liaison contact for given key customers as appropriate.
• Review, analyse and report on relevant customer complaints.
• A primary degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering)
• A minimum of 5 years work 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:
Conor Cronin | Tel: +353 (0) 1 5079258