Senior Director, Quality NEW

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. This role 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.

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. The Sr. Director 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.

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 the company 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 Qualifications:

• Minimum of a bachelor’s degree plus 10 years of related work experience or an equivalent combination of education and work experience
• Minimum of 10 years of experience leading a team
• Minimum of 10 years of experience operating in medical device quality systems environment in quality operations, design assurance, or quality system’s functional role
• Demonstrated knowledge in post-market surveillance, CAPA, management controls, risk management quality system elements, design change management process and manufacturing quality operations
• Demonstrated experience in managing FDA inspections, notified body audits

Preferred Qualifications:

• Ability to influence and excel in collaborative leadership
• Excellent communication skills; written and oral across all organization levels including division leadership and global quality leadership
• Hands-on orientation with a strong work ethic
• A strong focus on customer satisfaction
• High level of integrity and dependability with a strong sense of urgency and results-orientation
• Lean business/VIP experience