Cache of job #14130807

Job Title

Senior Quality Assurance Engineer


CareerWise Recruitment




A Senior Quality Assurance Engineer is required by Careerwise recruitment to work for our Galway based medical device manufacturing client. THE ROLE: * Provision of on-going regulatory compliance, risk management, design control, quality systems and overall design assurance expertise and leadership to the EMEA Packaging & Labelling Design & Development Centre of Excellence team on an on-going basis. * Provision of regulatory and quality systems leadership to the team as it transitions to Packaging & Labelling Design Ownership (Design Authority. * Liaison with corporate, local and EMEA sites quality systems and regulatory affairs personnel to ensure team's compliance and to drive alignment and harmonization. * Monitoring of the release and updates to regulatory & quality standards, regulations and policies, execution of gap analysis, communication of changes to the team and driving compliance. * Driving the implementation, maintenance and update of procedures that ensure packaging and labelling design controls are met. * Creating and maintaining risk management documentation. REQUIREMENTS: * Bachelor's Degree Level 8. * A minimum of 5 years' relevant experience in a Design Assurance - Quality Engineering field in a medical device or other FDA 21 CFR 820 or ISO 13485 regulated environment. * Must have experience in the preparation for and participation in ISO audits. * Experience in packaging and labelling design assurance very desirable. Please call Michael O'Connor today for further information on 091-452410 or email CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

Date Added

10 days ago