RAQA Automation & Digital Transformation Lead, Envista

Job Description:

POSITION SUMMARY
 

This position is based on‑site and requires four days per week in the Brea office to support collaboration and business needs.

The RAQA Automation & Digital Transformation Lead serves as the enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation, AI, and data driven capabilities. This role sets the strategic direction for RAQA digital enablement, ensuring the organization evolves into a more efficient, predictive, and globally harmonized function. The leader will drive high impact transformation initiatives that strengthen compliance, reduce manual burden, and unlock scalable, future ready processes across the RAQA ecosystem. 

ESSENTIAL DUTIES & RESPONSIBILITIES

Strategic Leadership & Vision 

• Define and own the multiyear RAQA digital transformation strategy, aligning automation and AI initiatives with enterprise priorities, regulatory expectations, and operational needs. 

• Establish a clear vision for a digitally enabled RAQA function, including intelligent workflows, predictive analytics, and automated compliance capabilities. 

• Serve as the senior advisor to RAQA leadership on digital trends, emerging technologies, and opportunities to accelerate efficiency and compliance. 

Automation & AI Program Ownership 

• Lead the identification, prioritization, and execution of automation and AI initiatives across Quality Control, Quality Systems, Regulatory Affairs, PostMarket Surveillance, and Document Control. 

• Oversee the development and deployment of intelligent document processing, automated data flows, AI assisted risk assessments, and digital inspection tools. 

• Ensure all solutions are validated, compliant, and seamlessly integrated into the QMS and enterprise systems. 

Operational Excellence & Process Redesign 

• Drive end to end process simplification and standardization through Kaizens, value stream mapping, and digital workflow redesign. 

• Champion the transformation of QC operations through automation, digital work instructions, and AI enabled defect detection where appropriate. 

• Build dashboards, analytics, and real time visibility tools that elevate decision making and strengthen audit readiness. 

Change Leadership & Global Adoption 

• Lead global change management efforts to ensure successful adoption of new digital tools and processes across all RAQA teams. 

• Develop training, communication, and capability building programs to elevate digital fluency within the organization. 

• Partner with regional RAQA leaders to ensure consistent deployment and sustained adoption across global sites. 

Regulatory & Compliance Stewardship 

• Ensure all digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements. 

• Oversee documentation, validation, risk assessments, and audit ready evidence for all automation and AI initiatives. 

• Collaborate with RAQA to ensure AI enabled processes remain transparent, defensible, and compliant. 

CrossFunctional Influence & Collaboration 

• Partner with Operations, IT, R&D, and