Senior Quality Engineer
Hartley People
Waterford, Tipperary, Wexford
Our client, a well established manufacturing company are looking for a Quality Engineer to join their team on a 12 month contract. This is an opportunity to join an established company in a challenging and rewarding role with excellent opportunities for personal development. The Role: Work closely with R&D during the development and introduction of new products and technologies. Work with the R&D Team to ensure that all Quality Control Requirements for new products and technologies are defined and understood and that they are transferable and maintainable in a production environment. Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation. Provide validation support by approval of validation documentation associated with new product validations and technologies. Technically understand the process in question, and provide input to, development protocols, process validation protocols, inspections and analysis of results. Ensure agreement on acceptance criteria. Work with the Project Team to achieve a robust validated process that is in compliance with regulatory requirements and Global Requirements. Ensure that validation product is properly controlled, segregated and identified. Track, trend and report on Quality performance of new product introductions and technologies post validation. Drive the resolution, analysis and problem solving of new product related issues, working closely with both manufacturing Quality and R&D. Lead CAPA/Non-conformance activity when required. Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products. Ensure all appropriate documentation is in place prior to production start. Provide updates to the site Plant Quality Plan as required. Ensure that cGMP are followed at all times and maintain good documentation practices for Work instructions, SOP’s and Forms. Additional requirements of the job will be specified by the Quality Validation Manager. The Person: Third level Qualification in Science or Engineering. Minimum 5 years’ experience in a regulated pharmaceutical/medical device environment in a Senior Quality Role essential. Full understanding and experience of the requirements of ISO 13485 and 21 CFR Part 820 and Part 11 essential. Must have Experience in providing Quality Support for Production Development and validation. Must be able to plan, organize, and deal with concurrent tasks and projects. Must have excellent analytical skills, and be able to analyse and provide Quality Direction on product / equipment issues using independent judgement, statistical tools and in accordance with Global Specifications and Regulatory Standards. Must be self-motivated, with ability to work on own initiative and prioritise. Must have experience of team working and excellent communication skills. Must have the ability to motivate and influence people and drive corrective actions when necessary. Strong attention to detail. Must have Statistics/Six Sigma Qualification. Must have good computer skills. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Pairic on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Analytical Chemist, Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, Formulation Scientist, Development Technologist.
2518 days ago