We are supporting a rapidly growing, innovation-driven technology company operating at the intersection of artificial intelligence, healthcare, and data science. Their mission is to deliver cutting-edge AI-powered solutions that support decision-making, improve outcomes, and enable scalable, compliant deployment of advanced technologies across regulated environments.
Overview
We are seeking a highly motivated Senior Quality Assurance Specialist to join an expanding team. This role will play a critical part in ensuring that AI-driven products, systems, and processes meet the highest standards of quality, compliance, and regulatory integrity.
You will work cross-functionally with product, engineering, data science, and regulatory teams, supporting the development and deployment of AI-enabled solutions in line with applicable quality standards
This position is ideal for someone who combines strong QA expertise with an understanding of software, data systems, or AI environments, and who thrives in a fast-paced, evolving organisation.
Responsibilities
Quality Management & Compliance
- Maintain and enhance the Quality Management System (QMS) in line with applicable standards (e.g. ISO 13485, ISO 9001, GxP as relevant)
- Ensure organisational compliance wi3th internal quality policies and external regulatory requirements
- Support quality strategy aligned with product and organisational growth
Audit & Inspection Readiness
- Lead and support internal and external audits, including regulatory inspections
- Prepare audit documentation, responses, and corrective action plans
- Drive audit readiness across cross-functional teams
Process Development & Improvement
- Design, implement, and continuously improve quality processes, SOPs, and documentation frameworks
- Identify areas for improvement and drive process optimisation initiatives
- Support scalability of QA processes in a high-growth environment
Product & Development Quality Oversight
- Partner with engineering and data science teams to embed quality standards across the product lifecycle
- Review and approve documentation related to:
- Software development
- AI/ML model validation
- Data governance and integrity
- Ensure traceability, validation, and documentation are audit-ready
Risk Management
- Conduct and support risk assessments (e.g. FMEA, risk logs) related to products and processes
- Ensure appropriate mitigation strategies are implemented and tracked
Skills & Experience
Essential
- Bachelor’s degree in a relevant field (e.g. Life Sciences, Engineering, Computer Science, or related)
- Significant experience in Quality Assurance within regulated environments (e.g. pharma, biotech, medtech, or digital health)
Strong knowledge of:
- QMS frameworks (ISO 13485, ISO 9001, or similar)
- Regulatory and compliance principles (GxP, data integrity, audit readiness)
- Experience supporting audits and inspections
- Strong understanding of documentation, SOP development, and process control
- Excellent organisational skills with high attention to detail
- Ability to work effectively in a cross-functional, matrixed environment
Desirable
- Experience working with AI/ML systems, digital health platforms, or software products
- Familiarity with:
- Software development lifecycle (SDLC)
- Validation practices for digital or AI-based products
- Experience in high-growth or start-up environments
- Knowledge of emerging regulatory frameworks for AI (e.g. EU AI Act, SaMD guidance)
- Professional certifications (e.g. CQI, Six Sigma, Quality certifications)
If you are interested, please apply or send me a message – jamie.keith@cpl.com
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