Quality Assurance Specialist – Medical Devices

Company: Cpl Life Sciences
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Job Description:

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. 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.

Quality Management & Compliance Maintain and enhance the Quality Management System (QMS) in line with applicable standards (e.g. 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 Design, implement, and continuously improve quality processes, SOPs, and documentation frameworks 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 Software development Data governance and integrity Risk Management Conduct and support risk assessments (e.g. FMEA, risk logs) related to products and processes 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) Regulatory and compliance principles (GxP, data integrity, audit readiness) Experience supporting audits and inspections Experience working with AI/ML systems, digital health platforms, or software products Software development lifecycle (SDLC) Validation practices for digital or AI-based products Knowledge of emerging regulatory frameworks for AI (e.g. CQI, Six Sigma, Quality certifications)…

Posted: June 2nd, 2026