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Sr Supplier QA Engineer

Work mode:  Hybrid Preferred, Remote Considered
Onsite Location(s): 

Marlborough, MA, US, 01752

Recruiter: Spencer Gregory Hale


Senior Supplier Quality Engineer.


This position could require you to support business that operates on Indian Standard Time (10-14 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: 577119

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.  

Nearest Major Market: Boston

Job Segment: Medical Device, QA Engineer, Compliance, Medical Device Engineer, Quality Engineer, Healthcare, Engineering, Legal

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