Senior Director Quality Systems

About the role The Sr Director leads the Neuromodulation Quality Systems team to ensure that the company quality system policies and procedures are effectively implemented and maintained. The role reports to the VP Global Quality – Neuromodulation and leads a team of quality managers and specialists who apply the quality system work instructions and processes needed to deliver safe and effective products that meet regulatory compliance. The Sr Director serves as the Valencia site Management Representative, interfaces with manufacturing, R&D, PMO, CMC/CIS, RA, Med/Safety, Design Assurance, and franchise leaders, and directs quality system forums including management review, CAPA review meetings and complaint management. This position is onsite at the Valencia office, requiring presence 4 days per week. Your Responsibilities Oversee implementation and monitoring of CAPA processes, post‑market surveillance, document and records controls across the Neuromodulation franchises. Ensure monitoring systems are maintained and trend signals for product performance, materials and supplier controls, post‑market feedback, non‑conformances and CAPAs are appropriately responded to; escalating relevant events that require field action. Coordinate data analysis, KPIs, production and process controls for management reviews, issue escalation, CAPA review board and complaint review board. Lead inspection and audit readiness preparation and audit/inspection response activities. Stay current on external and internal quality system changes, assess impact on the division, and implement updates as necessary. Ensure compliance with company policies and relevant federal, country or regulatory requirements. Create and develop a high‑performing quality systems team that fosters CAPA, risk management, management review, quality training and talent development. Collaborate with corporate quality systems SMEs to improve division compliance performance. Maintain weekly and monthly quality system status reports for VP updates to division leadership. Explore opportunities for AI and other tools to drive continuous improvement and sustained compliance across the division. Build strong, sustaining relationships with Production, Engineering, Corporate, Regulatory, external regulatory bodies and others; demonstrate teamwork and core values. Mentor and coach individuals and teams to develop performance and embody BSC core values. Communicate quality policies, strategies and procedures through written documents, presentations and discussions. Required Qualifications Minimum of a Bachelor’s degree and at least 10 years of related work experience (or equivalent combination of education and experience). At least 10 years of experience leading a quality team. At least 10 years of experience operating in a medical device quality systems environment—including quality operations, design assurance or quality systems functional roles. Demonstrated knowledge in post‑market surveillance, CAPA, management controls, risk management, design change management, and manufacturing quality operations. Demonstrated experience managing FDA inspections and notified‑body audits. Preferred Qualifications Ability to influence and excel in collaborative leadership. Excellent written and oral communication skills across all organization levels, including division leadership and global quality leadership. Hands‑on orientation with strong work ethic. Strong focus on customer satisfaction. High level of integrity, dependability, sense of urgency and results orientation. Lean business or VIP experience. Compensation Minimum Salary: $181,200. Maximum Salary: $344,300. Compensation will be commensurate with experience, qualifications and location. Variable compensation may include overtime, shift differential, annual bonus target and long‑term incentives for exempt roles. Legal and Compliance Requirements Boston Scientific Corporation is an equal‑opportunity employer. All personnel decisions are made 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. Positions located in the U.S. may require proof of COVID‑19 vaccination status. The employer will notify candidates during the interview and selection process if the role requires proof of vaccination as a condition of employment. The employer will also conduct a prohibited‑substance test for safety‑sensitive positions. #J-18808-Ljbffr Boston Scientific