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Supplier Quality Engineer Manager, SFMD

Work mode:  Hybrid
Onsite Location(s): 

Marlborough, MA, US, 01752

Recruiter: Spencer Gregory Hale


Supplier Quality Engineer Manager, SFMD


About the role:

The Supplier Quality Engineering will play an integral part in leading a team in the pursuit of improving the performance of Sourced Finished Medical Device (SFMD) suppliers to consistently meet Boston Scientific’s requirements. This individual will demonstrate a primary commitment to patient safety and will be responsible for collaborating with suppliers and cross-functional internal teams to ensure product quality meets our customer’s expectations.


Your Responsibilities will include:

  • Implement a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Develop direct reports by securing appropriate training, assigning progressively challenging tasks, providing performance-based feedback, applying progressive disciplinary action as appropriate, and conducting formal written and verbal performance reviews.
  • Champion a positive team-first culture and consistently demonstrates Boston Scientific’s core values. Participates in and supports Diversity, Equity, and Inclusion initiatives across the company.
  • Contribute to the development and monitoring of budgets through regular analysis of cost and spending.
  • Monitor daily work operations and provides direction and guidance to team.
  • Translate organizational and department goals into individual objectives. Proactive contribution to the development of operational policies and procedures.
  • Communicate effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience.
  • Build strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.
  • Direct team personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
  • Implement improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
  • Ensure sustaining support of SFMD products by delegating project work and prioritizing resources to improve product performance, minimize backorder, and reduce cost.
  • Interact with internal and external customers for proactive continuous improvement initiatives and critical issue resolution.
  • Ability to be front room facing for internal, corporate, and external audits and inspections.


What We’re Looking for in You:

Minimum Qualifications:

  • BS degree in engineering or technical field with minimum of 6 years of relevant experience.
  • Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
  • Experience in global supplier management or supplier quality engineering role strongly desired.
  • Experience in process validation, design controls, risk management, and CAPA a plus.
  • Ability to work independently and collaborate with project teams and management; organized and self-driven.
  • Strong knowledge of medical device regulations and standards including FDA 21 CFR 820, ISO 13485, EU MDR, ISO 14971, IEC 60601.
  • Domestic and international travel up to 25%.


Requisition ID: 573565

Among other requirements, Boston Scientific maintains specific prohibited substance test 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.  

Nearest Major Market: Boston

Job Segment: Quality Engineer, Medical Device Engineer, Quality Manager, Aeronautical Engineering, Medical Device, Engineering, Quality, Healthcare

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