Senior Quality Director

Boston Scientific•Maple Grove, MN

2d•$173,100 - $328,900•Onsite

About The Position

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.

Requirements

Minimum of a Bachelor’s degree
Minimum of 15 years of progressive experience in Quality or a closely related field
Minimum of 5 years of direct or indirect leadership experience, with demonstrated success leading teams, programs, or major initiatives
Experience in the medical device industry or another highly regulated environment
Experience working with applicable regulatory requirements – including ISO 13485, MDD/MDR, FDA QMSR, Health Canada, ANVISA, TGA, NMPA and other international requirements as applicable
Experience working with external regulatory bodies and post-market surveillance regulations
Experience working with third-party vendors

Nice To Haves

Advanced degree in a relevant discipline
Experience managing large-scale, complex programs, projects, business systems, and information technology within the Quality and compliance domain
Experience working with acquisitions and due diligence efforts
Demonstrated problem solving capabilities, high sense of urgency, and commitment to execution
Strong business and financial acumen, with the ability to quickly assess impact and consequences
Demonstrated ability to collaborate and influence across a global, matrixed organization
Ability to make consequential decisions in a high-pressure environment, whilst bringing along stakeholders
Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally
Ability to promote a high-performance, diverse, and inclusive culture within a quality-focused environment
Demonstrated commitment to people leadership through coaching, listening, and developing team members

Responsibilities

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: Lead, develop, and empower the team to achieve goals, deliver high-quality outcomes, and build organizational capability. Foster a culture of accountability, collaboration, and continuous improvement while supporting talent development, succession planning, and strong performance management.
Collaborate with stakeholders: Partner with leaders across Quality, Regulatory, R&D, Manufacturing, Clinical, and Risk Management to drive consistent Quality System execution and high-quality complaint investigations and trending. Align on investigation priorities, data needs, escalation criteria, and timely actions such as CAPA, risk updates, and design or process improvements. Collaborate with quality peers to share best practices and promote alignment across the organization.