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. They are responsible for monitoring product and process quality systems, reporting to the division president and quality vice president, and serving as the Valencia site Management Representative.

This role reports to the VP of Global Quality – Neuromodulation and leads a team of quality managers and specialists who apply the quality system work instructions and processes necessary to ensure safe and effective products are delivered to patients, meeting regulatory compliance requirements.

Onsite from the Valencia office location (4 days per week).

• Oversee monitoring systems implementation and response to CAPA process, post‑market surveillance, document and record controls across Neuromodulation franchises.
• Ensure monitoring systems are implemented, maintained and trend signals are appropriately responded to for product performance measures, document and record controls, material and supplier controls, post‑market feedback, non‑conformances and CAPAs. Escalate as necessary.
• 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.
• Understand and implement emerging external and internal quality system changes and their impact.
• Monitor and ensure compliance with company policies and regulatory requirements.
• Create and develop a strong quality systems team fostering CAPA, risk management, management review, training and talent development.
• Collaborate with corporate quality SMEs to improve division quality system compliance performance.
• Maintain weekly and monthly status reports for VP updates to division leadership.
• Explore application of AI and other tools to drive improvement and sustained compliance.
• Build strong relationships across Production, Engineering, Corporate, Regulatory, external bodies, and be an excellent team player.
• Demonstrate commitment to developing people, mentoring and coaching with visible core values.
• Communicate quality policies, strategies and procedures through written documents, presentations and discussions.

• Minimum of a Bachelor’s degree plus 10 years of related work experience or equivalent combination.
• Minimum of 10 years of experience leading a team.
• Minimum of 10 years operating in a medical device quality systems environment.
• Demonstrated knowledge in post‑market surveillance, CAPA, management controls, risk management, design change management and manufacturing quality operations.
• Experience in managing FDA inspections and notified body audits.

• Ability to influence and excel in collaborative leadership.
• Excellent written and oral communication skills at all organization levels.
• Hands‑on orientation with strong work ethic.
• Strong focus on customer satisfaction.
• High integrity, dependability, urgency and results orientation.
• Lean business/VIP experience.

Minimum Salary: $181,200. Maximum Salary: $344,300. Compensation may include variable components such as bonuses and incentives.

Boston Scientific Corporation is an equal opportunity employer. All employment 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.