Boston Scientific Principal Supplier Quality Engineer SFMD 

United States, Massachusetts, Marlborough 

713926177

Spencer Gregory Hale

Sustaining Engineering:

• Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Supports the evaluation of proposed changes at suppliers.
• Communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Review and approve supplier corrective action plans and verification of effectiveness documentation.
• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.

New Product Development:

• Lead the execution of SFMD Quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers and innovative medical devices.
• Generate/review quality plans, agreements, product specifications, component qualifications, and process validations. Assess readiness at supplier and support implementation.

Quality System and Culture Champion:

• Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development.
• Leads cross-divisional and cross-functional projects that deliver improvements to quality systems and processes.

• Provides mentorship and coaching to junior engineers; identifies others’ challenges and helps them reach higher work standards.
• Champions 100% compliance to company policies and SOP’s.

What we’re looking for in you:

Minimum Qualifications

• BS degree in engineering or technical field with minimum of 8 years of relevant experience.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Experience in process validation, design controls, risk management, and CAPA.
• Communicates effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience.
• Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.
• Ability to influence cross functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Ability to work independently and collaborate with project teams; organized and self-driven.
• ISO 13485 lead auditor of quality systems experience. Strong knowledge of FDA 21 CFR 820 and EU MDR.
• Travel up to 25%.

Preferred Qualifications

• Lean Six Sigma and equivalent certifications.
• Experience in global supplier management and supplier quality engineering role.

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.