Quality Assurance Specialist
HybridChorley, England, United Kingdom
Job Summary
Manage the site's Quality Management System (QMS), including the Quality Manual, SOPs, work instructions, and associated documentation. Lead the implementation and control of quality system documentation to ensure compliance and operational effectiveness. Manage the CAPA programme, ensuring timely investigation, implementation, effectiveness review, and closure of corrective and preventive actions. Plan and conduct internal audits in accordance with ISO 9001, ISO 13485, QSR, and other applicable standards. Support customer, supplier, and regulatory audits, including preparation, responses, corrective actions, and closure activities. Coordinate supplier quality activities, including evaluations, performance reviews, and audit programmes. Monitor quality trends and performance metrics to identify opportunities for continuous improvement. Lead or support Lean, Six Sigma, and Kaizen initiatives to strengthen quality systems. Support validation activities, including protocol preparation, testing, and documentation. Drive the implementation and optimization of quality management software systems, including ETQ Reliance modules. Deliver training on quality processes and continuous improvement methodologies. Evaluate emerging regulations and industry best practices to support ongoing compliance. This role is based on-site with a minimum of two days per week in the office.
Required Qualifications
- 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
- This role is based on-site, with a requirement to work from the office for a minimum of 2 days per week
Desired Qualifications
- 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
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