Sr Supplier QA Engineer

Recruiter: Yuan Pu

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: 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.