Npi Quality Engineer
CAREERWISE RECRUITMENT
SLIGO
An NPI Quality Engineer is required by CareerWise Recruitment for our Sligo based client. If you are interested in New Production Introduction with a company in Sligo then this is the position for you. THE ROLE: * Support the Quality Engineering elements of related processes, updating and improving the Quality Management System as required. * Maintain the Quality Notification process for the management of CAPA, vendor CAPA, MRB, Customer Complaints, and similar related activities. * Maintain strong relations with our customers to ensure all product specifications are clearly understood. * Provide support to the areas of Validations, Metrology, Document Control, performing Internal Auditing. * Provide input from a quality perspective to product & process risk assessments, pFMEA. * Have overall responsibility for reporting on GMP compliance in working area, and at all times, promote same throughout the facility. * Ensure environmental monitoring is performed and reported on in a timely manner. * Lead the establishment of Quality Engineering activity associated with new products introduced to the site, to achieve a successful handover to the Operations Group post Validation. * Work very close with the Validation Function within the site to ensure complete transparency and accuracy of validation & verification documentation generated in support of the new product introduction approval effort. * Ensure ongoing compliance, as applicable, with ISO13485 and other related Guidance Documents. REQUIREMENTS: * Bachelor's degree in Quality Management/ Quality Assurance / Engineering or equivalent industry experience. 2 years' experience in a similar role in the Medical Device Industry. * Knowledge of ISO, MDD, FDA requirements essential. Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie. 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.
1491 days ago