Senior Director, Quality
On-site · Los Angeles, California, United States
Job Summary
Senior Director, Quality leadership to oversee Neuromodulation Quality Systems, ensuring effective implementation of quality policies and procedures; lead monitor signals and KPIs across CAPA, post-market surveillance, document and records controls, and supplier controls; partner with Manufacturing, R&D, RA, and Regulatory teams to drive end-to-end quality performance, audit readiness, and continuous improvement; responsible for escalation of non-conformances, data analysis for management reviews, and fostering a strong quality culture with focus on CAPA, risk management, training, and talent development; requires cross-functional collaboration, strong communication, and experience in FDA inspections and notified body audits; expects a bachelor’s degree plus 10 years of related experience and demonstrated leadership in medical device quality systems.
Required Qualifications
- Bachelor’s degree
- 10+ years of related work experience
- 10+ years leading a team
- 10+ years of experience in medical device quality systems/quality operations
- Post-market surveillance knowledge
- CAPA, risk management, design change management, manufacturing quality operations
- Experience managing FDA inspections and notified body audits
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