Sr Supplier QA Engineer - Shanghai, 中国 - Boston Scientific

    Boston Scientific
    Boston Scientific Shanghai, 中国

    发现在: Talent CN S2 - 1周前

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    描述

    Recruiter: Yuan Pu

    Senior Supplier Quality Engineer.

    This position could require you to support business that operates on Indian Standard Time hour difference from the US time zones).

    About the role:

    This Senior Supplier Quality Engineer will be responsible for:

    1. 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.
    2. Leading and/or supporting individual, as well as cross-functional, continuous improvement projects.
    3. 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.

    Key responsibilities include:

    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.