Supplier Quality Engineering Manager - External Operations (Endoscopy)

Recruiter: Spencer Gregory Hale

 

 

Supplier Quality Engineering Manager – External Operations (Endoscopy)

 

About this role:
The External Operations Supplier Quality organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Manager will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes and grow the team. The role will focus on leading a team of Supplier Quality Engineers through supplier onboarding, new product launches, sustaining programs, and value improvement projects for Single-Use Devices and Capital Equipment. The manager will ensure the external manufacture of high-quality products and facilitate compliance with regulatory requirements.

 

Your responsibilities include:

• Lead team through New Product Development by coordinating with management, project leaders, & divisional core team members.
• 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.
• Monitor department’s activities and quality records to ensure compliance and timely execution
• Support Quality System and Regulatory standards including ISO 13485, 21CFR, MDSAP, EU MDR
• Front-room audit support in Regulatory Body Audits
• Engage with cross functional stakeholders to prioritize sustaining projects for each franchise. 
• Respond resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands  

• Monitor day-to-day operations and provide direction and guidance to employees on their divisional or project goals.
• Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.

• Effectively communicate with internal Stakeholders and Suppliers
• Contribute to the development and monitoring of area budgets through regular cost analysis and spending.
• Foster a diverse and inclusive workplace enabling all participants to contribute to their full potential in support of organizational objectives.

• Attract, develop, manage, and retain top talent. Ensure employees receive ongoing feedback, mentoring, training, development opportunities, and progressively challenging tasks.

• Align the vision, mission, and values in decision-making and actions.

 

What we’re looking for in you:
Minimal requirements:

• Bachelor’s degree required in Engineering, Science, or related technical discipline
• 7+ years of related and progressive quality experience within the medical device industry
• Strong facilitation & communication skills with the ability to successfully interact at all levels of the organization with proven ability to lead individuals, complex projects, and solve difficult technical problems.
• Highly adaptable, willing to accept new ideas, and ability to create, influence, and implement global strategies and policies successfully

• Effective communicator skilled in tailoring information to the intended audience.

• Experience collaborating with global teams and suppliers, including both U.S.-based and international regions.
• Ability to travel 20%

 

Preferred qualifications:

• Demonstrated success leading teams and mentoring individuals
• Advanced technical or business degree
• Background in Supplier Quality, Global Sourcing or Operations
• Experience working with contract manufacturers or OEM suppliers
• Proficient in MS Excel, Word, Project, PowerPoint, and ERP Systems
• Lead Auditor Certification (ISO 13485 or similar)
• ASQ certification (CQE, CBA, SSGB, SSBB) preferred
• Strong foundation in Material Controls and Quality Management Systems
• Skilled in collaborating with functions such as Quality Systems, Manufacturing Engineering, Sourcing, Regulat