Boston Scientific · 1 month ago
Senior Quality Manager, CDx Services
USA
Full-time
Hybrid
Senior Level, Lead/Staff
$116K/yr - $221K/yr
8+ years expBoston Scientific is a leader in medical science dedicated to solving important health industry challenges. The Senior Quality Manager, CDx Services is responsible for providing leadership and expertise in maintaining an effective quality system while ensuring compliance with quality and regulatory requirements.
Health CareMedicalMedical Device
No H1B
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering, or related technical/science-based field
Minimum of 8 years of experience in Quality or Operations roles within a regulated industry (medical device, pharmaceutical, or related)
Strong knowledge of Quality Systems and regulatory requirements (ex: FDA, EU MDR, ISO 13485)
Demonstrated experience with process ownership, CAPA management, and compliance leadership
Proven track record of leading cross-functional initiatives and influencing stakeholders at peer group and 1-up level
Demonstrated experience in people leadership, including managing, coaching, and developing teams
Minimal travel required
Preferred
Advanced degree (MS, MBA, or equivalent)
Experience with complex systems within a regulated business
Knowledge of EKG arrhythmia and the adjudication of such
Strong strategic thinking capability with the ability to balance long-term vision with executional excellence
Experience supporting a wide range of employee groups
Ability to drive change in a matrixed organization
Willingness to drive and complete actions when situation arises
Excellent collaboration, communication, and interpersonal skills with the ability to work across locations
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
Company data provided by crunchbase