Quality Engineer III

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\nBoston Scientific is seeking a highly motivated Quality Engineer III on a permanent basis to join our team. \n\nJob Purpose:\n\nDemonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Committed to patient safety and product quality.\n\nKey Responsibilities:\n\n * Takes a preventive approach to Quality Assurance, proactively identifying potential issues.\n * Uses strong organisational skills and effective time management to ensure work is completed in a timely manner.\n * Effectively prioritises a diverse workload to ensure timely completion of critical tasks.\n * Plans and executes both daily tasks and long-term projects to ensure timelines are met.\n * Takes a pragmatic and logical approach to challenges faced.\n * Explains technical topics clearly to diverse stakeholders through effective communication.\n * Promotes a culture of continuous improvement through reflection and factoring in previous learnings.\n * Makes informed decisions related to product quality, including dispositioning non-conforming product.\n * Evaluates complex quality issues and selects the most appropriate problem-solving tools/ techniques.\n * Documents non-conformances using a high standard of technical writing.\n * Reviews Complaints\u2019 signals and completes investigations for individual events/ unfavourable trends.\n * Familiar with BSC Quality Systems and ISO/MDD/MDR standards.\n * Involved in internal and external audits, including audit facing and presenting processes/ documents to auditors as a subject matter expert.\n * Knowledgeable on Risk Management, Design Outputs and product/ process Risk Documentation.\n * Uses appropriate statistical tools for sampling, capability, trend analysis, and control charts. Effectively interprets and presents conclusions drawn.\n * Participates directly in a new product/technology transfer, ensuring compliance to all internal and regulatory requirements.\n * Uses knowledge of Six Sigma, Statistical Analysis and Lean Principles to solve problems effectively.\n * Involved in change control for work instructions, protocols/ reports and technical documents, either as a change owner or quality approver.\n * Evaluates new equipment/processes/chemicals for safety and environmental impact/effect, in conjunction with EH\u0026S.\n * Completes validations for processes/ test methods in line with requirements and best practices.\n * Maintains relationships and gives technical guidance to Quality Engineers and Quality Technicians.\n * Deals with suppliers, other engineering disciplines within and outside of the site as required.\n\n\n\nEducation \u0026 Experience:\n\n * Honours Bachelor Degree (level 8) or equivalent in a STEM discipline.\n * A minimum of 5+ years relevant experience, within the Medical Device industry or another highly regulated environment.\n * Experience in validation activities.\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