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Principal Supplier Quality Engineer

4 months ago

Maple Grove, Minnesota, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

Principal Supplier Quality Engineer

About the role:
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 Principal 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.

This is a hybrid role with the expectation to be in the office 2 daysa week. This position will be located in Maple Grove, MN.

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.

Minimum qualifications:

  • BS degree in engineering or technical field with 9 years or MS degree and 7 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.
  • Experienced in Problem Solving methodologies; including the ability to lead multifaceted investigations across complex supply chains.
  • Experience in process validation, design controls, risk management, and CAPA.
  • Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
  • Domestic and international travel up to 25%.

Preferred qualifications:

  • Ability to work independently; organized and self-driven.
  • Articulate communicator adept at packaging and appropriately scaling information to the intended audience.
  • 7+ years of medical device engineering experience.
  • Experience with catheter design and/or manufacturing.
  • Previous support for high volume manufacturing.
  • 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.
  • Fluent in Spanish

Requisition ID:579500

Among other requirements, Boston Scientific maintains specificprohibited substancetest 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.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran