Senior Quality Assurance Specialist

Senior Quality Assurance Specialist focuses on maintaining and enhance the quality management system (qms) in line with applicable standards (e.g. iso 13485, iso 9001, gxp as relevant).

What the role involves

• Maintaining 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.
• Supporting quality strategy aligned with product and organisational growth.
• Support internal and external audits, including regulatory inspections.
• Preparing audit documentation, responses, and corrective action plans.
• Driving audit readiness across cross-functional teams.

Skills and requirements

• 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).
• Experience supporting audits and inspections.
• Experience working with AI/ML systems, digital health platforms, or software products.

Confirmed role details

• Design, implement, and continuously improve quality processes, SOPs, and documentation frameworks.
• Drive process optimisation initiatives.
• Support scalability of QA processes in a high-growth environment.
• Partner with engineering and data science teams to embed quality standards across the product lifecycle.

Candidate fit

• technical problem-solving, careful delivery, documentation discipline, and clear communication with stakeholders