Sr Supplier QA Engineer
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:
- 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: 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, Medical Device Engineer, Compliance, QA, Quality Assurance, Healthcare, Engineering, Legal, Quality, Technology