Senior Director Quality Systems

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. Collaborate with corporate quality systems SMEs to improve division quality system compliance performance 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. 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 systems 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 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