Documentation Clerk III

Reporting to: R&D Manager Structural Heart Closing Date: 12th February 2025 Our Mission: At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care. We are seeking a Documentation Clerk III on a permanent basis to join us on our mission. Purpose: You will maintain and implement Windchill in support of quality systems and practices to meet BSC, customer and regulatory requirements within the R&D Structural Heart Development team. Responsibilities:

• Provide documentation and Windchill support to own department and associated cross-functional teams within Structural Heart and NPD.
• Detailed review of CNs prior to routing for approval to ensure adherence to GDP, documentation procedures and quality requirements.
• Networking: Represents SH R&D for documents and part-based issues relating to project planning. Builds relationships with other functional areas and departments within the Structural Heart and NPD functions. Masters, explains and applies BSC data management tools (Windchill, SAP and MyBuy).
• Detailed understanding of BSC documentation procedures and basic understanding of ISO13485 and CFR/GMP requirements.
• Detailed understanding of procedures relating to Windchill. Process Improvement - Using own initiative, initiate and complete continuous improvement projects as requested.
• Provide support and coaching to SH NPD team for documentation requirements and Windchill functionality.
• Provide feedback to SH Leadership team on CN tracking, metrics and Windchill reporting where required.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

• NFQ level 7 180 credits required
• 4 to 5 years’ experience in quality or technical type role within new product development or production environment
• Science or Engineering background is desirable but not mandated
• Using and navigating Windchill is essential.
• Strong attention to detail.
• Good written and verbal communication skills.