Supplier Quality Manager

Supplier Quality Manager

This role presents a fast paced and dynamic leadership opportunity within the Global Supplier Quality Engineering organization. This individual will be responsible for leading a team of Supplier Quality Engineers that have subcategory ownership of direct materialsuppliers across North America manufacturing sites and products. SQE's are core members of multi-functional Global Sourcing Category Teams that define and execute sourcing strategies. They take an active ownership role within the Material Controls QS sub-process, owning assessments for supplier onboarding and surveillance of the Approved Vendor List, and supporting internal and external QSM audits. They work with BSC suppliers and cross-functional partners to resolve material related quality and yield issues, while providing quality oversight of Incoming Quality Assurance (IQA). This individual will manage the SQE team to efficiently and effectively execute daily activities and projects including root cause problem solving, material cost reduction, and proactive continuous improvement. All to ensure the manufacture of the highest quality and reliability medical devices on the market, while maintaining compliance to regulatory and BSC QS requirements. You will work alongside a seasoned leadership team that is motivated to partner for success.

Your responsibilities will include:

• Keep the organization's vision and values at the forefront of decision making and action.
• Lead your team through setting a clear strategy and meeting objectives
• Foster a global culture to further BSC's vision
• Coach sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Lead team and projects to successful conclusions while achieving strategic milestones.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Identify and initiate cross-department, cross-business unit, and/or cross-site projects.
• Maintain and enhance cross-functional team relationships within the divisions, plants, and distribution centers across the entire BSC network.
• Monitor, evaluate, and provide summary reports on project progress and results.
• Provide project direction, coaching, and mentoring for engineering and technical team personnel.
• Build strategic and trusting relationships through collaboration and teamwork.
• Develop future leaders through partnerships and mentoring.
• Influence Sr. Management on potential improvements or enhancement to the quality system and processes.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, ISO, MDR regulations).
• Contribute to the development and monitoring of area budget.
• Provide appropriate issue oversight, risk evaluation, and action to mitigate impact to Boston Scientific

What we are looking for:

• Bachelor's degree in engineering or related technical discipline
• 6+ years of related quality engineering experience in a regulated environment
• 2+ years of experience serving in a manager, supervisor, or lead capacity
• Passionate about leading people to bring out their best
• Proven ability to get the day-to-day tasks completed efficiently to make time for individuals to develop professionally and personally, and to engage in projects that drive their passion(s)
• Ability to understand decision making in a risk-based environment
• Communicates effectively and concisely packages up information to deliver key points; appropriately scales communication style and depth according to the audience.
• Proven mind set of proactive continuous improvement
• Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.

Preferred qualifications:

• Prior experience within a quality function
• Working knowledge of Medical Device regulations, specifically Material Controls Quality System requirements or experience within a highly regulated industry
• Working knowledge of the CAPA process
• Experience in global supplier management and supplier quality engineering role strongly desired.
• ISO 13485 lead auditor of quality systems experience. Strong knowledge of FDA 21 CFR 820 and EU MDR.
• Experience in directly supporting external Notified Body audits
• Experience in working with Direct material component suppliers
• Experience with project management