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: 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.

Key outcomes / success measures:

• Effective execution in complaint investigation timeliness, quality, and consistency, with clear, risk-based conclusions and compliant documentation.
• Effective complaint data trending and signal detection, with timely escalation, sound decision-making, and appropriate linkage to CAPA, risk management, and field actions when needed.
• Strong QMS process performance for the site and division, including meaningful metrics, effective management reviews, audit readiness, and successful execution of continuous improvement actions.
• Demonstrated cross-functional partnership that drives product and process improvements, supports new product and acquisition integration, and enables alignment across divisional and enterprise quality stakeholders.
• A high-performing organization with strong leadership bench strength, engaged team members, and a culture of accountability, collaboration, and continuous improvement.

Required Qualifications: 

• 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

Preferred Qualifications: 

• 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

Requisition ID: 629065 

Minimum Salary: $ 173100 

Maximum Salary: $ 328900 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may 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 for exempt, non-sales roles may 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

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.