Lead, Digital Quality & Compliance

The Opportunity

This position works out of our Plano, Texas location in the Neuromodulation Division. Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

We are seeking a highly motivated and collaborative Digital Quality and Compliance Lead to drive digital transformation initiatives that improve quality intelligence, signal detection, regulatory intelligence, and proactive risk management across the product lifecycle. Individual contributor with comprehensive knowledge in automation and ability to execute highly complex or specialized projects. Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

This role will serve as the primary coordinator and business lead for a cross-functional transformation initiative focused on leveraging analytics, automation, AI-enabled insights, and external intelligence platforms to improve visibility into emerging quality, compliance, product performance, and patient safety risk. This role will work closely with Quality, Regulatory Affairs, Product Surveillance, Operations, R&D, IT, Privacy, and Cybersecurity teams to identify high-value opportunities, implement innovative solutions, and support adoption across the organization.

What You’ll Work On

Quality Systems Automation

• Develop, configure, and maintain automated workflows within QMS platforms and related enterprise systems.
• Identify opportunities to automate quality processes including CAPA, complaints, nonconformances, change control, audits, training, supplier quality, and document control.
• Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.
• Design system integrations between Quality, ERP, PLM, CRM, and Manufacturing Execution Systems (MES).
• Implement automation solutions that improve process consistency, compliance, and user experience.

Systems Administration and Compliance

• Support validation activities for computerized systems in accordance with company procedures and regulatory requirements.
• Maintain system configurations, user access controls, audit trails, and electronic records.
• Ensure compliance with FDA, EU MDR, ISO 13485, and data integrity requirements.
• Assist in preparation for regulatory inspections and audits by supporting system documentation and evidence generation.

Data Analytics and Reporting

• Develop dashboards and automated reporting tools to monitor quality metrics and KPIs.
• Analyze quality data trends and identify opportunities for process improvement.
• Support management review activities through automated data collection and reporting.

Continuous Improvement

• Lead digital transformation initiatives within the Quality organization.
• Collaborate with stakeholders to optimize business processes and eliminate manual activities.
• Apply Lean, Six Sigma, and risk-based methodologies to improve quality system effectiveness.
• Evaluate emerging technologies including AI and advanced analytics for quality applications.

Project Management

• Lead system implementation and enhancement projects.
• Develop project plans, requirements, testing protocols, and deployment strategies.
• May liaise with external vendors.
• Coordinate vendors, consultants, and cross-functional teams to ensure successful project execution.

Required Qualifications

• Bachelors degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or a related field.
• Experience with workflow automation, low-code/no-code platforms, or business process automation tools.
• Strong analytical and problem-solving skills.
• Excellent communication and stakeholder management abilities.

Preferred Qualifications

• Masters degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or a related field.
• 4+ years of experience supporting Quality Systems in a regulated industry.
• Experience with electronic QMS platforms such as Veeva, TrackWise, ETQ Reliance, or similar systems.
• Strong understanding of: FDA 21 CFR Part 820, 21 CFR Part 11, EU MDR / IVDR, ISO 13485, GAMP 5, Computer System Validation (CSV).
• Experience in medical devices, diagnostics, biotechnology, or pharmaceutical industries.
• Knowledge of Power Platform, Power Automate, Power BI or equivalent automation tools.
• Experience integrating QMS systems with ERP, PLM, or manufacturing systems.