Skip to main content
Johnson Jobs

Senior Supplier Quality Engineer - SFMD

intracept by boston scientificMaple Grove, MN

today

Occupations

Validation EngineersQuality Control Systems ManagersBioengineers and Biomedical Engineers

Industries

Surgical Appliance and Supplies ManufacturingElectromedical and Electrotherapeutic Apparatus ManufacturingSurgical and Medical Instrument Manufacturing
APPLY NOW (opens in a new tab)

About the role

Senior Supplier Quality Engineer – SFMDThe 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.
Your responsibilities include: Sustaining Engineering:
  • 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.
  • 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.
  • Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
  • Quality System Champion:
  • 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.
  • What we're looking for in you:
  • Minimal qualifications:
  • 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%.
Preferred qualifications:
  • 7+ years of medical device engineering experience.
  • Ability to speak Spanish in a professional setting
  • 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.
  • Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs.

Matching similar jobs

JOB OVERVIEW

Experience level

Manager

Location

Maple Grove, MN

Occupation

Validation Engineers

Industry

Surgical Appliance and Supplies Manufacturing

Posted

today

Tired of running searches?

Rank the roles you'd take once, and matches like these arrive on their own.

CREATE PROFILE (opens in a new tab)