Quality Engineer II

Diversity - 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\nAdvancing possibilities for a brighter tomorrow\n\nWe are seeking a Quality Engineer II on a permanent basis to join our team.\n\nPurpose Statement\n\nProvide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products.\n\nKey Responsibilities \n\n * Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying \u0026 bounding data to support implementation of complex \u0026 documenting release criteria.\n * Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs.\n * Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.\n * Assists in creation of Quality Tools \u0026 Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools \u0026 materials.\n * Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned.\n\n\n\nRequired Qualifications:\n\n * Level 8 Hons Bachelor Degree (or higher) in Engineering or related field\u200b\n * 3-5 years\u2019 experience in Manufacturing or Quality\n * Excellent written and verbal communication skills\n * Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems\n * Strong command of MS Office \u2013 Word, Excel, PowerPoint.\n * Ability to rapidly learn and use new applications\n * Previous experience in a Quality, or Manufacturing background.\n * Experience in the medical device industry.\n * Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls.\n * Experience in problem solving and process improvement methodologies.\n * Process Validation, Risk Management, CAPA experience.\n * Experience in Capital Equipment/EME processes desirable\n\n\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 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\nTo search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers\n\nAt Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please email [email protected].\n\n.\n