Senior Supplier Quality Engineer - SFMD

Boston Scientific; Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

Boston Scientific is seeking a Senior Supplier Quality Engineer for the SFMD organization to ensure the safety and performance of finished devices by supervising supplier quality activities across sustaining, new product development, and quality systems.

You will lead quality deliverables with cross-functional teams, drive CAPA, audits, validation, and supplier assessments, and ensure compliance with regulatory requirements while advancing supplier capabilities.

Qualifications

• BS degree in engineering or a technical field.
• 5+ years in medical device or regulated industry.
• Experience coordinating cross-functional teams.
• Familiarity with CAPA, risk management, design controls.
• Ability to travel up to 25%.

Responsibilities

• Sustain quality by evaluating issues with suppliers and tracking CAPA.
• Lead supplier audits and follow-up actions.
• Lead SFMD quality deliverables with cross‑functional NPD teams.
• Develop quality plans, specifications, product qualifications, and validations.

Skills

Problem solving

Project management

Communication

Travel

Education

Bachelor's degree in engineering

Tools

PLM

ERP

Job description

Senior Supplier Quality Engineer – SFMD

About the role: The Sourced Finished Medical Device (SFMD) organization at BostonScientific 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.

Responsibilities

• 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.

Qualifications

• Minimum 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 (ISO13485 or similar).
  • ASQ certification (CQE, CBA, SSGB, SSBB) strongly desired.

Equal Opportunity & Legal Statements

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.