Senior Supplier Quality Engineer - SFMD

Boston Scientific•Arden Hills, MN

37d•$85,000 - $161,500

About The Position

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.

Requirements

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.
Ability to work independently; organized and self-driven.
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).
Domestic and international travel up to 25%.

Nice To Haves

7+ years of medical device engineering experience.
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.

Responsibilities

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.
Champions 100% compliance to company policies and SOP’s.