Quality Assurance Specialist

Role Mission

As a Quality Assurance Specialist, you will play a key role in maintaining and continuously improving the site's Quality Management System (QMS), ensuring compliance with regulatory requirements, industry standards, and customer expectations. You will support quality leadership by driving quality assurance activities, managing CAPA and audit programmes, supporting supplier and customer quality initiatives, and leading process improvement efforts that enhance operational excellence and compliance across the business.

• Support the management and continuous improvement of the site's Quality Management System (QMS), including the Quality Manual, SOPs, work instructions, forms, and associated documentation.
• Lead the implementation, revision, and control of quality system documentation to ensure compliance and operational effectiveness.
• Manage and support the CAPA programme, ensuring timely investigation, implementation, effectiveness review, and closure of corrective and preventive actions.
• Plan, conduct, and lead internal audits in accordance with ISO 9001, ISO 13485, QSR, and other applicable standards.
• Support customer, supplier, and regulatory audits, including audit preparation, responses, corrective actions, and closure activities.
• Coordinate supplier quality activities, including supplier evaluations, performance reviews, and supplier audit programmes.
• Support complaint investigations, ensuring timely review, escalation, resolution, and closure in line with quality requirements.
• Monitor quality trends and performance metrics, identifying opportunities for continuous improvement and risk reduction.
• Lead or support Lean, Six Sigma, Kaizen, and other continuous improvement initiatives to strengthen quality systems and operational performance.
• Support validation activities, including the preparation and execution of protocols, testing, and documentation where required.
• Drive the implementation and optimisation of quality management software systems, including ETQ Reliance modules and related tools.
• Deliver training and guidance on quality processes, compliance requirements, and continuous improvement methodologies.
• Evaluate emerging regulations, standards, and industry best practices, providing recommendations to support ongoing compliance and business readiness.
• Collaborate cross-functionally with Operations, Supply Chain, Customer Service, and Leadership teams to promote a culture of quality and continuous improvement.

We’re looking for a proactive quality professional with experience working in regulated environments and a passion for continuous improvement. You will have strong knowledge of quality systems, auditing, and compliance, combined with the ability to influence stakeholders and drive meaningful change. This role is ideal for someone who enjoys balancing operational quality activities with strategic improvement initiatives.

• Experience supporting or managing Quality Management Systems (QMS) within a regulated environment.
• Strong knowledge of quality standards and regulations, including ISO 9001, ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and/or similar regulatory frameworks.
• Experience conducting internal audits and supporting customer, supplier, or regulatory audits.
• Knowledge of CAPA processes, complaint handling, non-conformance management, and root cause analysis methodologies.
• Strong documentation control experience, including SOP development, review, and implementation.
• Excellent problem-solving and analytical skills with the ability to identify trends and drive improvements.
• Experience working with quality software systems and electronic quality management systems (eQMS).
• Strong communication and stakeholder management skills, with the ability to influence at all levels of the organisation.
• Excellent organisational skills and the ability to manage multiple priorities and deadlines.
• Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
• Ability to work independently while collaborating effectively within cross-functional teams.

• Bachelor's degree in Quality, Life Sciences, Engineering, Business, or a related discipline.
• Previous experience within medical devices, pharmaceuticals, biotechnology, clinical trials, healthcare, or other GxP-regulated industries.
• Lead Auditor qualification or formal auditing certification.
• Experience with ETQ Reliance or other electronic Quality Management Systems (eQMS).
• Knowledge of EU MDR (745/2017) and IVDR (746/2017) regulations.
• Lean Six Sigma Green Belt certification or experience applying Lean, Six Sigma, or Kaizen methodologies.
• Experience supporting validation programmes and qualification activities.
• Experience managing supplier quality programmes and supplier audits.
• Project management experience, particularly within quality or compliance-focused initiatives.
• Experience supporting global quality or regulatory compliance programmes.