The External Operations Supplier Quality organization at Boston Scientific needs to oversee a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Manager 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, ensuring the external manufacture of high-quality products and facilitating compliance with regulatory requirements.
Requirements
- 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.
- Proficient in MS Excel, Word, Project, PowerPoint, and ERP Systems
- Lead Auditor Certification (ISO 13485 or similar)
Responsibilities
- 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.
- Provide manufacturing support at external vendors by addressing manufacturing process defects and implementing process improvements utilizing Quality System tools.
Other
- Bachelor’s degree required in Engineering, Science, or related technical discipline
- Ability to travel 20%
- Demonstrated success leading teams and mentoring individuals
- Attract, develop, manage, and retain top talent. Ensure employees receive ongoing feedback, mentoring, training, development opportunities, and progressively challenging tasks.
- Foster a diverse and inclusive workplace enabling all participants to contribute to their full potential in support of organizational objectives.
