PRINCIPAL SUPPLIER QUALITY ENGINEER, SFMD

Recruiter.
Spencer Gregory Hale   Principal Supplier Quality Engineer, SFMD   About the role.
The Principal Supplier Quality Engineer will play an integral part in leading the performance improvement of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scientific’s requirements.
This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets our customer’s expectations.
Your responsibilities will include.
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.
Supports external regulatory body audits as required.
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 lead auditor of quality systems experience.
Strong knowledge of FDA 21 CFR 820 and EU MDR.
Travel up to 25%.
Preferred Qualifications Experience with medical software validation and cybersecurity.
Lean Six Sigma and equivalent certifications.
Experience in global supplier management and supplier quality engineering role.
Requisition ID.
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.