Supplier Quality Engineer Manager, SFMD

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.