Senior Supplier Quality Engineer - SFMD

The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior Supplier Quality Engineer will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes.

* Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation.

* Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers.

* 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.

* Lead the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.

* Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

* Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents.

* Identifies and advises management on potential improvements to quality systems and processes in the company.

* BS degree in engineering or technical field with 5 years relevant experience.

* Experience in the medical device, automotive, aeronautical, semiconductor, or other regulated industry.

* Project management: the ability to influence cross-functional global teams spanning quality, operations, R&D, and sourcing.

* Experience in process validation, design controls, risk management, and CAPA.

* Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.

* Ability to rapidly learn and use new software applications (e.g., PLM, ERP).

* Leadership experience on a materials or service commodity team.

* Lead auditor of quality systems experience (ISO 13485 or similar).

* ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.