Sr Supplier QA Engineer - Shanghai, 中国 - Boston Scientific

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    描述

    About the role:

    This Senior Supplier Quality Engineer will be responsible for:

  • Managing a continuous improvement project portfolio focused on simplifying business processes and increasing robustness of quality processes related to sourced finished medical devices in the APAC region.
  • Leading and/or supporting individual, as well as cross-functional, continuous improvement projects.
  • Leading and/or participating in appropriate BSC Communities of Practice to ensure the global processes continuously execute quality outputs at the highest industry/company level.
  • Minimum requirements

  • Engaging internal and external stakeholders to define and advance continuous improvement opportunities aligned with our Best4 Quality strategy (Best Culture, Best Agility, Best Performance, Best Compliance) and Global Sourcing strategy.
  • Establishing effective communication methods and cadence for reporting project statuses/updates.
  • Championing standards, processes, and best practices across the SQE organization. Serving as a mentor to the SQE community on an as needed basis.
  • Supporting ad hoc requests and special projects, as needed.
  • Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Travel 10-20% may be required.
  • What we're looking for in you:

    Minimum requirements

  • Minimum of a bachelor's degree in engineering with 5+ years related experience in a medical device manufacturing, quality, or regulatory/compliance environment
  • Strong project management, organizational, and written and verbal communication skills
  • Flexibility in work hours to accommodate global meetings
  • Continuous improvement mindset with a passion for Quality
  • Preferred qualifications:

  • Previous experience managing OEM medical device suppliers
  • Understanding and practice of the FDA, ISO, and the medical device industry quality requirements
  • Prior interactions with the following disciplines: manufacturing engineering, post market surveillance, CAPA, risk management, and process engineering
  • Experience managing individual and cross functional projects
  • Requisition ID: 579772

    Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.