Description
I have an immediate opening for a Quality Engineer with a leading medical device company based in Dublin.This is a fantastic opportunity to join a company working in fast paced high volume manufacturing facility that offers that offer excellent career opportunities for progression.
Reporting to the Quality Engineering 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 and liaison with key customers.
Responsibilities:
*Be a key driver of cGMP practices within Operations and Quality divisions
*Provide support for the ISO 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.
*Review, analyse and report on relevant customer complaints
Educational Requirements:
*A primary degree in a Science/Engineering discipline (Preferably Polymer Science/Engineering or Mechanical Engineering)
Relevant Experience:
*A minimum of 5 years work experience in an ISO 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 are interested in hearing more about this excellent opportunity please apply directly to this advert ort contact Derek Sheridan on for immediate consideration.