Quality System Specialist - Field Action (FA) Process

Additional Locations: Spain-Madrid; Italy-Milan; United Kingdom-Hemel Hempstead\n\nDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance\n\nAt Boston Scientific, we\u2019ll give you the opportunity to harness all that\u2019s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we\u2019ll help you in advancing your skills and career. Here, you\u2019ll be supported in progressing \u2013 whatever your ambitions.\n\n \n\n \n\nBackground\n\nWe are seeking an additional resource to support Field Action execution and to drive ongoing FA related process improvement initiatives, within the European, Middle East and Africa (EMEA) Region.\n\n \n\nRole Overview\n\nThe Quality System Specialist will play a pivotal role as a Regional Field Action Coordinator (RFAC), supporting the EMEA Field Action Process. This individual will be part of a dedicated team responsible for planning, executing, and closing field actions, as well as identifying and implementing process improvement initiatives in collaboration with impacted stakeholders.\n\n \n\nThis role involves close partnership with Global, Regional, and in-country Quality FA teams, as well as cross-functional stakeholders in Marketing, Regulatory Affairs, and Customer Care. Success in this position requires excellent interpersonal skills and stakeholder management experience, with a strong focus on process efficiency, while ensuring adherence to quality system requirements that meet Boston Scientific, customer, and regulatory expectations.\n\n \n\nThis a a hybrid position, which means working three days from the office and two days from home.\n\n \n\nKey Responsibilities\n\n * Manage the EMEA Regional Field Action process execution steps in accordance with defined procedures.\n * Collaborate with cross-functional teams (Regulatory, Quality, Customer Care) to ensure stakeholder understanding and expectations in relation to Field Action activities.\n * Represent EMEA Quality Regional FA Team in cross-functional meetings and improvement workstreams\n * Support the execution of EMEA FA process improvement initiatives.\n * Communicate effectively across all levels of the organisation, tailoring messaging to audience.\n * Influence decision-making through clear articulation of risks, trade-offs, and business impact.\n * Assist with audits and inspections related to field action processes.\n * Ensure timely and accurate documentation of NCEP/CAPA investigations in accordance with established procedures in relation to the Field Action Process.\n\n\n\n \n\nQualifications \u0026 Requirements\n\n * 5\u20137 years of experience in Quality System Management within the medical device or related industry.\n * Knowledge of the Field Action execution process.\n * Demonstrated ability to collaborate effectively in a global, matrixed organization.\n * Experience leading cross-functional initiatives to completion.\n * Ability to work independently, and within a team, in a dynamic environment.\n * Strong interpersonal, communication, and influencing skills.\n * Excellent decision-making, prioritization, problem-solving, and time management abilities.\n * High sense of urgency and commitment to execution in a fast-paced setting.\n\n\n\n \n\n \n\nRequisition ID: 615207\n\nAs a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \u2013 united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do \u2013 as a global business and as a global corporate citizen.\n\nSo, choosing a career with Boston Scientific (NYSE: BSX) isn\u2019t just business, it\u2019s personal. And if you\u2019re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!\n