Principal Quality Specialist

<p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Additional Locations:</strong></span></span> Ireland-Galway; France-Voisins le Bretonneux; Germany-Düsseldorf; Ireland-Clonmel; Ireland-Cork; Italy-Milan; Netherlands-Kerkrade; Spain-Madrid; United Kingdom-Hemel Hempstead</p><p style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance</strong></span></span></p><p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">At Boston Scientific, we’ll give you the opportunity to harness all that’s 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’ll help you in advancing your skills and career.

Here, you’ll be supported in progressing – whatever your ambitions.</span></span></p><p> </p><p><strong><span style="text-decoration: underline;">About the role:</span></strong></p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">The Principal Quality Specialist serves as a senior Quality leader supporting large-scale, complex initiatives within the Medical Electrical Equipment (MEE) / Capital Equipment domain. You will</span><span style="color: black;"> drive the development, implementation, and governance of quality frameworks across global, cross-functional programs.</span></p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">We are looking for a candidate with strong leadership in quality systems, project execution, and organizational change, ensuring alignment with regulatory requirements, corporate quality goals, and operational excellence. </span><span style="color: black;">The role operates with a high degree of autonomy and influences strategic decision-making across multiple functions and regions.</span></p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">This position will be either hybrid or onsite located at Kerkrade in the Netherlands or at one of the EMEA Hub locations.</span></p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="text-decoration: underline;"><strong><span style="color: black; text-decoration: underline;">Key Responsibilities:</span></strong></span></p><ul style="margin-bottom: 0cm; margin-top: 0px;"><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Lead Quality activities for complex, cross-functional Medical Electrical Equipment (MEE)/Capital Equipment programs, ensuring delivery against objectives, milestones, and timelines through robust project planning and risk mitigation.</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Drive execution across regional and global teams, aligning Quality, Regulatory, Supply Chain, Service, and commercial functions while proactively managing risks, issues, and dependencies.</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Serve as a subject matter expert in Quality Systems, ensuring compliance with applicable regulatory standards such as ISO 13485</span><span style="color: black;">, </span><span style="color: black;">EU MDR 2017/745, and 21 CFR Part 820, and embedding scalable Quality frameworks across all program phases from concept through sustainment.</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Lead or support CAPA, root cause analysis, and continuous improvement initiatives to resolve systemic issues and enhance overall performance.</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Collaborate with cross-functional colleagues regarding the impacts of enhancements and process changes.</span></li></ul><ul style="margin-top: 0cm; margin-bottom: 0cm;" type="disc"><li style="color: black; margin-bottom: 0cm; line-height: normal; margin-top: 0cm; margin-right: 0cm; font-size: 12pt; font-family: Aptos, sans-serif;">Is viewed as a leader in the areas of QSR and ISO/MDR standards within one’s own group, constantly promoting awareness of best industry practices making appropriate decisions while collaborating with EMEA Quality leaders as appropriate on critical quality decisions.</li></ul><ul style="margin-bottom: 0cm; margin-top: 0px;"><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Drive change management and cross-functional engagement by influencing decision-making, building stakeholder alignment, and enabling adoption of new processes, systems, and ways of working in a matrixed global organization.</span></li></ul><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><strong><span style="text-decoration: underline;"><span style="color: black; text-decoration: underline;">Requirements:</span></span></strong></p><ul style="margin-bottom: 0cm; margin-top: 0px;"><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Bachelor’s or Master’s degree in engineering, Quality, Life Sciences, or related field </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">5+ years Quality Systems experience in within Medical Devices / Medical Electrical Equipment (MEE) / Capital Equipment.</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Previous experience in Capital Equipment space is preferable. </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Proven experience leading large-scale, cross-functional and/or global programs </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Experience in change management and transformation initiatives</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Team player with strong work ethics and positive mentality</span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: normal; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Strong project and program management capability </span></li></ul><ul style="margin-top: 0cm; margin-bottom: 0cm;" type="disc"><li style="color: black; margin-bottom: 0cm; line-height: normal; margin-top: 0cm; margin-right: 0cm; font-size: 12pt; font-family: Aptos, sans-serif;">Strong interpersonal communication, collaboration and influencing skills</li></ul><ul style="margin-bottom: 0cm; margin-top: 0px;"><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Deep regulatory and quality systems knowledge </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Excellent stakeholder management and influencing skills </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Structured, analytical mindset </span></li><li style="margin: 0cm 0cm 0cm 0px; line-height: 15pt; font-size: 12pt; font-family: Aptos, sans-serif;"><span style="color: black;">Ability to operate effectively in ambiguous or evolving environments, where requirements are not fully defined.</span></li></ul><p style="margin: 0cm 0cm 8pt; line-height: 115%; font-size: 12pt; font-family: Aptos, sans-serif;"> </p><p> </p><p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Requisition ID: </strong>631768</span></span></p><p> </p><p><span>Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world.

As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.

Learn more at </span><a href="https://c212.net/c/link/?t=0&l=en&o=4007299-1&h=2437349916&u=https%3A%2F%2Fwww.bostonscientific.com%2F&a=www.bostonscientific.com" target="_blank" rel="noreferrer noopener"><span>www.bostonscientific.com</span></a><span> and follow us on </span><a href="https://www.linkedin.com/company/boston-scientific/" target="_blank" rel="noreferrer noopener"><span>LinkedIn</span></a><span>.</span></p>