Senior Quality Manager, CDx Services

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role: At Boston Scientific, the Senior Quality Manager, CDx Services is responsible for providing leadership, subject matter expertise, and process stewardship across the CDx Services business, ensuring that systems, processes, and staffing are suitably designed and implemented to maintain an effective/active quality system. This role plays a critical part in shaping CDx Services strategy, ensuring compliance to quality and regulatory requirements (including reportability), and driving operational excellence. The Quality Manager will work with their group to ensure safety, reliability, and quality of cardiac reports, and related outputs, through the effective use of quality planning, risk analysis, statistical methods and process controls during the design and production stages of the report build process. Exceed customer expectations by responding to post market feedback and field events in a professional and timely manner.  Minimize the number of field events through effective analysis of information/data, corrective actions and timely investigation and response to post market feedback and field events. Reduce costs by employing quality and reliable system processes that result in the development of efficient test and inspection plans, improved yields, and minimized rework.

The successful candidate will excel at building strong relationships, understanding the interdependencies across holistic CDx operations, and identifying future strategic capabilities. They will guide a diverse team, influence an assorted set of stakeholders, and serve as a trusted advisor in CDx Services quality matters. This role also includes managing and developing a team (4-8 direct reports) in the Auditing, Post Market, Quality Assurance and Process Quality function with the Service-based business.

 

 

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week.

 

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

 

Your Responsibilities Include:

• Lead, coach, and develop team to build expertise, accountability, and long-term talent capability within the organization.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.  May supervise non-exempt employees.
• Keeps the organization's vision, values and objectives at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, Medicare, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules to achieve department objectives.
• Develop, monitor, and appropriately adjust the annual budget for department(s), as necessary.
• Provides appropriate level of cross-functional and customer-oriented communication regarding the status of department and quality system operation, as well as product performance.
• Influence and collaborate with a diverse stakeholder base to adapt processes, represent the voice of quality, and drive adoption of best practices.
• Build and sustain networks across the overall CDx business group to ensure aligned processes and consistent execution.

 

Required Qualifications:

• Bachelor’s degre