RAQA Automation & Digital Transformation Lead, Envista

POSITION SUMMARY
 

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

TheRAQA Automation & Digital Transformation Leadserves 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 acrossQuality 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 withRAQAto ensure AI enabled processes remain transparent, defensible, and compliant.

CrossFunctional Influence & Collaboration

• Partner withOperations,IT, R&D, andMarketingto ensure alignment and integration of digital initiatives.

• Represent RAQA on enterprise digital transformation committees, steering groups, and governance bodies.

• Influence senior stakeholders through clear communication, strong business cases, and datadriven insights.

QUALIFICATIONS

• Bachelor’s degree in Engineering, Computer Science, Quality, Regulatory Affairs, or related field; advanced degree preferred.

• 7+ years of experience in RAQA, Quality Systems, Regulatory Affairs, Manufacturing or Digital Transformation within medical devices, diagnostics, or life sciences.

• Demonstrated success leading enterprise level automation, AI/ML, or digital transformation programs.

• Demonstrated success implementing inspection automation, test automation, or digital QC systems.

• Deep understanding of QMS processes, regulatory requirements, and validation of digital/automation tools.

• Proven ability to lead global teams, influence senior stakeholders, and drive change in complex environments.

• Exceptional communication, strategic thinking, and program management capabilities.

LEADERSHIP PROFILE

A successfulcandidatewill:

• Operate as a strategic architect of RAQA’s digital future.

• Translate complex regulatory and quality challenges into scalable digital solutions.

• Build momentum and alignment across global teams.

• Deliver measurable efficiency, compliance, and capability improvementsYOY.

• Serve as a visible champion for innovation, simplification, and continuous improvement.

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