8 of 8 Permanent ISO 13485 Jobs in the South East

outcomes. About the Role We're hiring a QA Compliance Manager to lead a team focused on maintaining and enhancing the Quality Management System (QMS) in compliance with GMP, ISO 9001, ISO 13485, and other regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits, while … potential Qualified Person (QP) sponsorship for the right candidate. Key Responsibilities: Lead and develop the QA Compliance team Maintain and improve the QMS in line with EU GMP and ISO standards Oversee internal audits, CAPA management, and batch documentation review Host customer audits and support regulatory inspections Drive continuous improvement and contribute to strategic quality initiatives Support training, change … in a scientific discipline (e.g. Chemistry, Biology, or related field) 10+ years' experience in GMP-regulated environments Strong leadership and people management skills In-depth knowledge of EU cGMP, ISO 9001, and ISO 13485 Experience supporting or conducting batch release under QP supervision Lead Auditor training and a proactive approach to quality improvement Excellent communication, organisation, and More ❯

to proactively identify and mitigate risks. Work closely with the security team to integrate best practices into new and existing features. Ensure compliance with security standards and regulations (e.g., ISO 27001, SOC 2). Implement monitoring solutions to detect and respond to real-time security incidents. Troubleshoot infrastructure and security issues, performing root cause analysis in production. Mentor junior … cloud platforms (AWS, GCP). Experience with security tools like OWASP ZAP, Burp Suite, etc. Familiarity with Jira, Confluence, or similar tools. Knowledge of compliance frameworks (e.g., GDPR, HIPAA, ISO 27001, ISO 13485). Background in start-up or scale-up environments is a plus. Key Attributes: Strong collaboration skills. Eagerness to learn and upskill in new More ❯

settings and bring clarity to complex technical challenges. This opportunity is ideal for someone with a background in medical device development, particularly within implantable or regulated systems. Familiarity with ISO 14971, ISO 13485, and verification methodologies will be key, alongside strong communication skills and a detail-oriented mindset. If you're looking to make a meaningful impact More ❯

the product from design to manufacturing, solving engineering issues in electronics, firmware, and production instrumentation Maintain, adapt, and optimise existing firmware within the constraints of regulatory compliance (IEC 62304, ISO 13485) Lead electronics design, schematic capture, and PCB layout using Altium Develop LabVIEW applications for test and instrumentation Collaborate with manufacturing partners to troubleshoot and resolve production issues More ❯

EKS). An understanding of Linux system administration and networking concepts would be useful Any experience of working within a regulated setting and working to one or more of: ISO 13485, 27001, 9001 would be advantageous The list above is important, but not as important as hiring the right person! So if you don't meet all of More ❯

improvement in patient outcomes. Your new role As QA Compliance Manager, you'll lead a team responsible for maintaining and improving the Quality Management System in line with GMP, ISO, and regulatory standards. Reporting to the Head of Quality, you'll oversee internal audits, batch record reviews, CAPA systems, and customer audits. You'll also contribute to strategic quality … discipline (e.g. Chemistry, Biology, or related field) Extensive experience in GMP-regulated environments (10+ years preferred) Strong leadership and people management skills In-depth knowledge of EU cGMP and ISO standards (9001, 13485) Experience supporting or conducting batch release under QP supervision Lead auditor training and a proactive approach to continuous improvement Excellent communication, organisational, and stakeholder engagement More ❯

supporting clinical trials and ensuring compliance with international standards. Key Responsibilities Define and document system architecture, design inputs, and interfaces. Lead risk management activities (FMEA, FTA) in compliance with ISO 14971. Maintain technical documentation (DHF) for audits and regulatory submissions. Manage system and sub-system requirements with full traceability. Support clinical investigations and verification testing. Collaborate with cross-functional … and regulatory. Drive process improvements and stay current with evolving standards. Skills & Experience Essential: Degree in engineering or a related field. Experience in regulated medical device development. Familiarity with ISO 14971 & ISO 13485. Strong understanding of system-level requirements and V&V principles. Desirable: Experience with implantable or active medical devices. Knowledge of IEC 60601, IEC 62304, or … ISO 14708. Proficiency with document control and requirements management tools. Experience working with clinical and academic partners. Whats on Offer Competitive salary based on experience. Private healthcare, income protection, life assurance. Company pension scheme. 27 days holiday plus bank holidays. Hybrid working. The opportunity to contribute to a transformative medical technology platform. More ❯

Familiarity with SysML, CAD, and simulation software. Experience with analytical methods for FEA/CFD validation. Understanding of MBSE, systems thinking, and PDM. Knowledge of regulated development frameworks like ISO 13485. Excellent communication and data presentation skills. Experience with statistical, experimental, and analytical methods for FEA/CFD validation. Managing CAD data anddocumentation within the PDM. Model-Based Systems … align our BZero sustainability initiative aim to be accredited to SBTI which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485. A full job description can be downloaded on the application Screen . Our core values are Customer Focussed, Respectful, Collaborative, and Agile these More ❯