Recruiter:Spencer Gregory HalePrincipal Supplier Quality EngineerAbout 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 days a 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 SpanishRequisition ID: 579500Among other requirements, Boston Scientific maintains specific prohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.
