Job Description

Additional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we\xe2\x80\x99ll give you the opportunity to harness all that\xe2\x80\x99s 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\xe2\x80\x99ll help you in advancing your skills and career. Here, you\xe2\x80\x99ll be supported in progressing \xe2\x80\x93 whatever your ambitions.Purpose StatementThe role supports the Regional Director, Quality Systems, in developing, establishing, and maintaining quality systems and practices which meet BSC, customer and regulatory requirements. Develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Provide quality engineering support within technical development concepts, new product development, operational, or system/services supportKey ResponsibilitiesServes as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, regional and Global quality goals and prioritiesEstablishes the industry benchmark for Quality Systems best practice, determines robust, practical, compliant solutions for the businessActs as regional subject matter expect for quality system processes, works closely with Subject Matter Experts (SMEs), the Manager, Quality Systems and the country affiliate teams, ensuring compliance with Boston Scientific Corporation policies / procedures and local regulatory requirements across the regionLeads the APAC internal audit process and programsDevelop, enhance and champion the quality awareness across all functions of the regionMay supports SME and Manager, Quality Systems in maintaining a high level of control of the process documentation and associated training across the regionLeads system improvement teams selecting appropriate techniques for problem solving and process improvementsApply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issuesTakes a role in the management and preparation of the regional management reviewChampions continuous improvement and innovation within the QA Dept. & Region. Manages and drives Value Improvement Projects across the region ensuring regional objectives are metCollaborate and Liaises with the Global Quality Systems team and relevant working groups to drive continuous improvementAct as team leader/member in supporting quality disciplines, decisions, and practicesAssure the development and execution of streamlined business systems, which effectively identify and resolve quality issuesAdvise management on potential improvements or enhancement to quality systems and processes in the companyUnderstands, interprets, and applies Documentation Control principles and processes to ensure compliance with Corporate, FDA, MDD, PAL, CMDCAS, ISO regulations and standards with unyielding integrityEnsures awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of Boston ScientificKey Requirements10+ years of experience in a QA related environment. Experience in the Medical Device or Pharma industryCertified ISO 13485 auditorGood understanding of APAC countries regulatory requirementsProven experience in a multi-national company with a matrix reporting structureSolid understanding of quality management system with experiencesPro-active, energetic, self-assured professional with ability to develop good interpersonal relationships with other entities of Boston ScientificExcellent communication skills with the ability to positively influence key stakeholders without direct authorityProficiency in Microsoft Excel, Word, and PowerPointCertifications in LEAN or Six Sigma will be a plusTenacity in following through on detailsRequisition ID: 585300As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most \xe2\x80\x93 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 \xe2\x80\x93 as a global business and as a global corporate citizen.So, choosing a career with Boston Scientific (NYSE: BSX) isn\xe2\x80\x99t just business, it\xe2\x80\x99s personal. And if you\xe2\x80\x99re 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!

Boston Scientific