Technical Documentation Specialist - Mdr
Dun Laoghaire, Dublin South
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey in ‘advancing the world of health’. Our facility in Dun Laoghaire has recently completed a large expansion plan and now produces the majority of pen needles for the diabetes market globally. Part of the expansion plan was to house a dedicated R&D department on site - This department is now up and running and we are looking for a highly talented Technical Documentation Specialist (2-year Contract) to provide technical input to a cross functional program team in the Diabetes Care business unit as it prepares for compliance with the EU’s new Medical Device Regulations. The Technical Documentation Specialist is a critical position responsible for all Technical Documentation readiness for Product Registration within the Diabetes Care (DC) Business Unit and will provide input as part of the larger BD wide Implementation of the MDR. This is a multi-million-euro Program with significant impact and visibility across BD. Responsibilities include: Will be responsible for leading the engineering change documentation process and creating/reviewing the redlined documentation package that accompanies it; such as Bills of Material, Tool/Fixture drawings, Artwork, Component drawings, Device drawings; Review document changes for adherence to Document Control procedures; Reviews and analyzes released engineering change data and coordinates changes with engineering, quality, manufacturing; Work with site personnel to develop documentation / Execute and track document changes / updates through the Document Control System (SAP ECC6); Collaborate with the project team and key stakeholders to understand documentation requirements and ensure effective resolution of document system queries or requests. The successful candidate will have 3+ years’ experience in a technical document role in medical devices or R&D. You will have a Primary Degree in Engineering, science or an equivalent technical subject. You will be an excellent communicator with ability to run meetings and workshops (face to face, conference call, Global Connect). You will be a good team player who has previous experience of working in a cross functional environment. You will be responsible for ensuring the effective administration and maintenance of the documentation system in line with regulatory requirements for product changes and updates. You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business. If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button. This job originally appeared on RecruitIreland.com.
79 days ago