Senior Quality Engineer

R.T.Lane Recruiting Talent

Wexford, Waterford

R.T.Lane Recruitment are looking for a Senior Quality Engineer for a Global Medical Devices company in Waterford. This is a Projects focused role, with strong skills required in Design Assurance, Validations, CAPA Mnaagement and NPI. Please call for details on this role today. 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/Nonconformance 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. Education and Skills: 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. Please dont hesitate to contact Rachel Lane for a more detailed Job description 022 46969 or email rachel@rtlanerecruitment.ie. This job originally appeared on RecruitIreland.com.

2624 days ago