A highly respected medical device client is looking for a talented Quality Engineer to join their team in Dun Laoghaire. The Quality Engineer on this project/new product will be the key Quality Engineering representative ensuring that all activities within the development and validation lifecycle adhere to both company and regulatory requirements.
• Be a key driver of cGMP practices within Operations and Quality divisions;
• Ensure design transfer activities are carried out such that all product design requirements are satisfied in a controlled manner through to shop floor introduction;
• Development of control plans;
• Provide support for the ISO9001/2000 and ISO13485 and 21CFR Part 820 Quality Systems;
• Responsible for ensuring adherence to all company and external regulatory requirements;
• 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.
• Third level qualification in an Engineering or Science Discipline;
• 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.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you would like further Information you can contact the recruiter directly:
Claire Kenny | Tel: +353 (0) 1 507 9287