Senior Quality Director

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, we are united by one purpose: transforming lives by addressing some of the most important challenges in healthcare. Patient care is at the center of everything we do, and quality, compliance, and patient outcomes are essential to delivering on that commitment.

The Sr. Director, Quality leads the team responsible for complaint investigation and analysis for the Interventional Cardiology and Vascular Therapies division. This role sets the strategy and operating model for complaint handling, coding, returned product analysis, data trending, and signal detection, helping the organization identify issues, make sound risk-based decisions, and drive product and process improvements. In addition, this leader oversees key Quality Management System (QMS) processes and governance for the Arbor Lakes site and the division, ensuring strong procedures, effective management reviews, meaningful metrics, audit readiness, and continuous improvement.

Reporting to the VP of Quality for Interventional Cardiology and Vascular Therapies, the Sr. Director, Quality partners closely with leaders across Quality, Regulatory, R&D, Manufacturing, Commercial, and other key functions. This role is responsible for delivering site and divisional objectives while helping align complaint handling and key QMS processes with broader enterprise standards.

This role is onsite at the Arbor Lakes location requiring you to be in office 4 days per week.

Your responsibilities include: 

•  Complaint investigation, coding, and returned product analysis: Own end-to-end execution and oversight of complaint investigations, including robust root cause analysis, consistent and accurate coding, and returned product analysis (RPA) where applicable. Ensure investigations are thorough, timely, and compliant, and drive meaningful conclusions that enable product and process improvements.
•  Complaint data analysis, trending, and signal identification: Lead the team responsible for analyzing complaint and returned product data to understand device performance, identify trends, and detect potential signals. Establish the governance, methods, and tools needed to support timely escalation, sound decision-making, and appropriate follow-through, including linkage to CAPA, risk management, design changes, and field actions when needed.
• Quality Management System (QMS) leadership (site and division): Own and govern assigned QMS processes and performance for a site and the Interventional Cardiology and Vascular Therapies division, ensuring procedures, controls, metrics, audit readiness, and continuous improvement are in place and effective. Drive alignment and harmonization with enterprise QMS requirements and ensure effective interfaces between complaint investigation, CAPA, risk management, and management review.
• New products and acquisitions integration: Provide Post Market/Quality Systems Management leadership for acquisition due diligence, integration, and ongoing sustainment.
• Infrastructure and project management: Lead projects and programs, in partnership with Quality Assurance colleagues and cross-functional teams, to ensure the organization has the infrastructure, systems, and tools needed to deliver strategic initiatives and business goals. Identify gaps, prioritize improvements, and drive execution of solutions locally and as part of broader global programs.
• Enterprise-level shaping: Shape enterprise quality strategy, standards, and operating models by representing divisional and site priorities in enterprise decisions. Partner across functions and divisions to drive alignment, standardization, and scalable solutions that advance business, regulatory, and patient needs.
• Strategic decision making: Make clear, timely, risk-based decisions across complaint handling, QMS governance, and business priorities. Apply sound judgment to complex issues, identify and escalate risk as appropriate, drive actions to resolution, and influence leadership to align on decisions that protect patients, ensure compliance, and support performance.
• People leadership: