Quality Assurance Engineer

Careerwise Recruitment

Westmeath

Quality Assurance Engineers required by CareerWise Recruitment for our Athlone based client in the New Product Introduction department. Responsible for providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for Supporting company goals, objectives, policies, procedures, quality systems, and FDA regulations. THE ROLE: * Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, Validations and FMEA's for both new product introductions and existing product line changes/process improvements. * Review and/or develop and execute facility, software, process and equipment validations and risk management documents. * Review change controls for process/design impact. * Use knowledge of statistics to assist with validation developments and process improvements. * Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines. * Assist in the analysis and resolution of problems that may reduce the efficient running of production lines. * Complete NCMR and CAPA investigation, processing and disposition. * Ensure continuous compliance for Product Manufacturing, Packaging and Labeling. * Assist in the development, analysis and improvement of site Quality Metrics. REQUIREMENTS: * Minimum of Degree in relevant engineering discipline. * 5 years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments. * Ability to share technical expertise with colleagues i.e. able to express information clearly and concisely both verbally and in written format. * Good problem solving abilities - able to identify facts, consider a number of alternative approaches and evaluate the most appropriate course of action. * Team and results orientated - committed and energetic approach to work with positive attitude. * Proven reliability - efficient, results-orientated and manages own time well. * Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude. * Six Sigma/lean expertise demonstrated in the manufacturing, process development and validation of new products is highly desired. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times. This job originally appeared on RecruitIreland.com.

2402 days ago