Quality Projects Engineer

CPL

Galway

Quality Projects Engineer. My Galway based client is now hiring a Quality Engineer for a Project based role, responsible for Quality within their prescribed project. This candidate will primarily be responsible for transfer of production documentation and developing / executing Validation documentation. Job Overview: Development and executing Validation documentation which aligns with the receiving sites Quality system. Maintain relevant documentation to comply with quality standards and customer requirements. Establishing inspection standards, plans, frequencies and test methods. Establish a production process documentation at the receiving site which aligns with sending site controlled process through transfer of all relevant documentation. Involved in preparing and updating Operations procedures and associated documentation while maintaining compliance with quality standards and customer requirements. Have a good working knowledge of ISO/FDA/MDD and other Manufacturing related regulatory requirements. Develop strong links with customer organisations and other project stakeholders. Performing an active role in further development and continuous improvement of the quality management system. Support Project Manager / Mentor Team Leaders / production teams to achieve business objectives & performance in line with Project goals and KPIs. Job Requirements: Degree in Quality or Degree in Science / Engineering. 5+yrs industry experience in a medical device-manufacturing or pharmaceutical environment. Working knowledge of FDA and ISO Quality systems for Medical device companies. New product introduction and manufacturing process transfer experience would be a distinct advantage. Experience in developing and executing Equipment and Process Validations. This job originally appeared on RecruitIreland.com.

1769 days ago