Spencer Gregory Hale
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, Regulatory, Research and Development, Design Assurance, and Project Management
- Proven ability to lead both onsite and virtual teams
- Experience recruiting & developing a high-performing talent
Maximum Salary: $ 197000
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
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.