Senior Director Quality Systems

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:

The Sr Director leads the Neuromodulation Quality Systems team to ensure that the company quality system policies and procedures are effectively implemented and maintained. He/She/They will be responsible for maintaining the monitoring of product and process quality systems utilizing standard performance metrics, trigger signals and routinely reporting to the division president, division quality vice president. They will serve as the Valencia site Management Representative.

This role reports to the VP global quality – Neuromodulation and leads a team of quality manager(s) and specialists who are responsible for the daily application of the quality system work instructions and processes necessary to ensure safe and effective products are being delivered to patients and conforming to regulatory compliance requirements. This role will interface with the manufacturing sites, R&D, PMO, CMC/CIS, RA, Med/Safety, Design Assurance teams, and franchise leaders to accomplish quality objectives. This role will direct the quality system forums including management review, CAPA review meetings, Complaint Management meetings, and assures that all actions are being prioritized and managed accordingly. This role will work closely with the Neuromodulation director of Design, Quality, director of Complaints Investigation and Trending, and the director of quality acquisition and integration, to establish a comprehensive end to end quality system culture and compliant performance distinction across the division.

This role is onsite out of the Valencia office location requiring you to be onsite 4 days per week.

Your responsibilities include:

• Oversee the necessary monitoring systems are implemented, and signals responded to for the CAPA process, post-market surveillance, document and records controls, across the Neuromodulation franchises. 
• Ensure that the necessary monitoring systems are implemented, maintained and trend signals are appropriately responded to for product performance measures, document and records controls, material and supplier controls, post market feedback, non-conformances and CAPAs.  Escalate as necessary all non-conformance events and product design and/or performance issues that require formal review and consideration of field actions.
• Serve as point of contact in coordinating data analysis, KPIs, production and process controls as necessary for management reviews, issues escalation, CAPA review board, and complaint review board.
• Lead inspection and audit readiness preparation and audit/inspection response activities.
• Understand emerging external and internal quality system changes and impact to the Neuromodulation division.  Ensure quality system updates are appropriately implemented.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements)
• Create and develop a strong quality systems team that fosters CAPA, risk management, management review, quality system training and talent development across the function.
• Collaborate with corporate quality systems SMEs to improve division quality system compliance performance
• Maintain weekly and monthly quality system status reports as necessary for VP updates to division leadership team.
• Foster opportunities for the application of AI and other tools to drive overall improvement and sustained quality system compliance across the division.
• Be recognized as a team player across the organization. Build a strong and sustaining relationship with Production, Engineering, Corporate and Regulatory, external Regulatory bodies and others and be recognized as an excellent team player within the total organization on site.
• Demonstrate commitment to developing people, mentoring and coaching individual and team performance while visibly demonstrating the core values of BSC in everyday leadership style.
• Communicate quality policies, strategies and procedures to the organization through written documents, presentations and discussions.
• Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements)

Required qualificat