Quality Assurance Engineer (Npi)

Careerwise Recruitment

Westmeath

A Quality Assurance Engineer for N.P.I. is required by CareerWise Recruitment for our Athlone based client. 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. Please contact Tom Devaney for more information. 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. * Perform Internal Audits/Supplier Audits. * Assist in the development, analysis and improvement of site Quality Metrics. * Lead/Support project activity in your area of responsibility. * Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation. * Actively contribute to the enhancement of compliance initiatives for areas of responsibility. * Will comply with all relevant training required and adhere to relevant associated documentation. * Follow strict adherence to the requirements of CGMP. * Liaise with suppliers to ensure drawings and specifications are clear, understood and fully compliant. REQUIREMENTS: * Level 8 Degree in Engineering or Science. * 5 years' experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments. * Strong computer skills (MS Excel, PowerPoint, Word etc.) * Familiarity with statistical tools such as Pareto charts and trend charts. * Familiarity with all aspects of Process Validation (IQ / OQ / PQ. * Familiarity with FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools. * Experience with problem solving techniques. * Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, 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. This job originally appeared on RecruitIreland.com.

1849 days ago