Description
I have an immediate opening for a Quality Engineer with a world renowned medical device company based in Dublin (Salary €45,000 -€50,000). Working within a fast paced environment this is an excellent opportunity to join a growing company that provides excellent training and work-life balance to their employees.Reporting to the Quality Manager, 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
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.
*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.
*A primary degree in a Science/Engineering discipline
This is an fantastic opportunity for ambitious Quality Engineers who looking for a role with a highly respected medical device company in Dublin. If you are interested in hearing more about this position please apply directly to this advert or contact Derek Sheridan on for a more detailed insight.