QA Excellence and AI Enablement Lead

Clinisys • Morrisville, NC

1d • $100,000 - $125,000 • Hybrid

About The Position

Building an AI‑first organisation is central to Clinisys’ purpose and the impact we deliver. As a global provider of intelligent diagnostic informatics solutions, we build AI‑enabled, cloud‑based platforms to enhance diagnostic workflows across healthcare, life sciences, and public health. By applying intelligent technology thoughtfully and responsibly, we help laboratories and testing environments operate more effectively, generate meaningful insights at scale, and ultimately support healthier and safer communities. Operating across more than 30 countries, Clinisys expects all colleagues—regardless of role or function—to work confidently with AI‑enabled tools, apply digital and analytical thinking, and continuously adapt as technologies evolve, must drive an AI first sense of purpose and urgency.
The QA Excellence & AI Enablement Lead is a senior individual contributor (matrix leader) responsible for advancing Quality Management System (QMS) excellence, regulatory compliance, and continuous improvement through the strategic and practical application of AI and digital capabilities. This role serves as a subject matter expert in quality systems, regulatory readiness, and AI-enabled process optimization, ensuring scalable, efficient, and compliant quality operations across the organization.
This position partners closely with Quality, Regulatory, R&D, Operations, IT, and business stakeholders to modernize quality processes, enhance decision-making through data and AI, and drive industry-leading quality performance—without direct people management responsibilities.
This role is based in Raleigh, NC with a requirement to be on-site 3 days per week.

Requirements

• Deep expertise in quality systems and regulatory requirements within regulated healthcare, medical device, laboratory, or life sciences environments.
• Strong understanding of AI concepts and applications relevant to quality, compliance, and operational excellence.
• Strong matrix leadership with a results-driven approach, including negotiation, timeline execution, and KPI delivery.
• Strong analytical, problem-solving, and systems-thinking capabilities. Proficient in creating bureaucracy-free processes.
• Ability to interpret complex regulations and standards and convert them into efficient, compliant, and technology-enabled processes.
• Excellent written and verbal communication skills, with the ability to influence across functions and organizational levels.
• High attention to detail combined with strategic perspective.
• Proficiency with electronic QMS platforms, digital workflows, data analytics tools, and AI-enabled solutions.
• Comfortable operating in a highly matrixed environment as a trusted advisor and thought leader.
• Bachelor’s degree in science, engineering, healthcare, or a related field.
• 5–10+ years of experience in Quality Assurance and/or Regulatory Affairs in a regulated environment (medical device, diagnostics, software as a medical device, or life sciences preferred).
• Demonstrated experience supporting audits, inspections, and regulatory compliance activities.
• Proven track record leading quality improvement initiatives or complex projects as a matrix leader.
• Forming relationships across the wide business organization to drive results and deliverables.
• Hands-on experience applying AI, automation, or advanced analytics to enhance quality processes, training, or decision-making.
• Strong knowledge of where to find, interpret, and apply regulatory requirements.

Responsibilities

• Serve as a quality systems and regulatory SME, supporting the development, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with applicable regulations and standards (e.g., ISO 13485, 21 CFR 820, EU MDR/IVDR), with specific attention, but not limited to, nonconformances, CAPA, complaints, risk assessments.
• Lead AI enablement within Quality, identifying, designing, piloting, and scaling AI- and automation-driven solutions to improve workload prioritization and forecasting, document management and review efficiency, training effectiveness and knowledge management, CAPA, risk management, and postmarket surveillance insights.
• Translate regulatory and quality requirements into practical, scalable, and digitally enabled quality processes.
• Act as a matrix leader and influencer, driving cross-functional alignment without direct authority.
• Provide quality leadership for document control and training systems, product lifecycle activities (design changes, risk management, postmarket surveillance) and investigations, nonconformances, and CAPA.
• Support internal and external audits and inspections, serving as a primary quality liaison and subject matter expert.
• Partner with Regulatory Affairs, IT, and Cybersecurity to ensure compliance with data integrity, AI governance, and country-specific regulations.
• Monitor regulatory changes and emerging AI-related guidance; assess impact and drive timely updates to procedures, tools, and training.
• Develop quality metrics and dashboards; analyze KPI trends to proactively identify risks and improvement opportunities.
• Review and approve quality records, investigations, and reports, ensuring accuracy, compliance, and timely escalation.
• Support quality planning for new products, services, digital solutions, and geographic expansions.
• Contribute to enterprise-wide quality excellence initiatives, best practices, and standardization efforts.

Benefits

• Our benefits for Full Time employees are designed to help you move forward in your career, and in areas of your life outside of work. From health and wellness benefits, 401 (k) Savings Plan, stock incentive programs, paid time off, parental leave, and tuition assistance, we've got you covered with our total rewards package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level