Description
I have an immediate opening for a Quality Engineer with a leading medical device manufacturer based in Dublin. This is an excellent opportunity to join a major player within the industry who are based in Dublin.Reporting to the Quality Manager, your 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, complaint management and problem solving. Experience working within a highly automated environment is desireable.
RESPONSIBILITIES:
- Be a key driver of cGMP practices within Operations and Quality divisions
- Provide support for the ISO13485 and 21CFR Part 820 Quality Systems
- Support production personnel in quality related matters and 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
- Be a primary contact for other departments providing quality advice / guidance to assure compliance.
- Manage compliance with relevant GMPs and promote quality improvements
- Ensuring adherence to internal and external regulatory requirements
- Become an active member of the site internal audit team, liaising with Regulatory auditors
RELEVANT EXPERIENCE:
- A minimum of 5 years work experience in an ISO or ISO13485 environment, coupled with a background in Medical Devices Industry.
- Primary degree in a Science/Engineering discipline
- Proven working experience with FDA and ISO 13485.
- Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).
- Experience in the preparation and review of Technical Documentation.
- Proven ability of working in a cross-functional team environment.
- Excellent interpersonal and communication skills and high level of computer literacy.
If you are interested in hearing more about the exciting opportunity please apply directly to this advert or contact Derek Sheridan on for immediate consideration.