22 of 22 ISO 13485 Jobs in the UK

recruit an experienced Quality Engineer to join their manufacturing team and support the ongoing development of their Quality Management System in line with ISO 13485 and regulatory requirements. This is an excellent opportunity for someone with a strong background in manufacturing who enjoys working across the full quality … CAPA management to validation, supplier quality and continuous improvement. Key responsibilities include: Maintaining and improving the Quality Management System (QMS) Planning and conducting ISO 13485 internal audits and supporting external audits Managing CAPAs, non-conformances, root cause investigations and change control Supporting supplier quality, validation activities and complaint ...

also lead improvements that reduce turnaround times, streamline processes, improve reporting, introduce best practice and prepare the department for future regulatory requirements, including ISO 13485 compliance. Why this role is unique: This isn't a typical service leadership role. You'll be working at the intersection of: • Assistive … systems. • Strong organisational skills with the ability to manage competing priorities. • Excellent written and verbal communication skills Desirable experience: • Medical devices and regulated products. • ISO 13485 and quality management systems. • Six Sigma methodologies. • CAPA investigations. • Business Central. • Electronics fault-finding to component level. If this sounds like ...

surveillance, complaint handling, quality engineering, and risk management within regulated industries. Knowledge of medical device regulations and standards, including EU MDR 2017/745, ISO 13485, ISO 14971, and 21 CFR 820. Excellent communication and stakeholder management skills, with the ability to work effectively across global cross ...

excellent communication skills, and the confidence to work under pressure on complex technical challenges. Experience with medical devices or quality management systems such as ISO 9001, ISO 13485, or ISO 14971 is highly desirable, though not essential for the right candidate. If you are driven … restore functionality & ensure devices remain safe & compliant. Quality and safety compliance -- Working within existing quality frameworks, contributing to documentation, risk assessments & adherence to ISO standards. Cross departmental support -- Providing secondary engineering support to the Radiotherapy department, assisting with maintenance activities on high precision treatment equipment. Collaborative service delivery -- Working ...

organisation. Present security risks and recommendations to senior leadership. Essential Experience 5+ years' experience in Information Security, Cybersecurity or Product Security. Strong experience with ISO 27001 and recognised frameworks such as NIST and OWASP. Experience conducting risk assessments, threat modelling and vulnerability management. Experience integrating security into software development … deliver pragmatic, risk-based solutions. Highly Desirable Medical Devices, HealthTech or Software as a Medical Device (SaMD). Product Cybersecurity experience. Knowledge of ISO 13485, ISO 14971, GDPR, HIPAA and FDA cybersecurity guidance. Experience with connected devices, mobile applications or cloud-hosted healthcare platforms. Qualifications Professional certifications ...

relevant machinery safety standards and company policies. Conduct risk assessments and implement safeguarding measures for automated equipment. Support compliance with quality management systems, including ISO 9001 and ISO 13485 where applicable. Maintain accurate engineering documentation, including electrical drawings, specifications, and validation records. Qualifications & Experience Essential Degree ...

short notice. Support product testing and validation during New Product Introduction (NPI). Complete build sheets, QA records and validation documentation in line with ISO 13485 and ISO 9001 requirements. Maintain test equipment calibration and process spare parts returns. Support Field Service Engineers on customer sites once ...

short notice. Support product testing and validation during New Product Introduction (NPI). Complete build sheets, QA records and validation documentation in line with ISO 13485 and ISO 9001 requirements. Maintain test equipment calibration and process spare parts returns. Support Field Service Engineers on customer sites once ...

maintain accurate car stock inventory records. Train customers on equipment use before and after installation. Complete accurate service reports and documentation in line with ISO 13485 and ISO 9001 requirements. Follow health and safety procedures and patient data requirements. Build strong, professional relationships with customers across ...

successful in this role, you will ideally have: Experience within Medical Devices, Diagnostics or another highly regulated manufacturing environment. Strong knowledge of ISO 13485 and Quality Management Systems. Experience managing CAPAs, non-conformances, complaints and root cause investigations. Knowledge of quality tools such as 8D, 5 Why, Fishbone … process improvement initiatives. Exposure to supplier quality, change control and risk management activities. Strong documentation and problem-solving skills. Experience with Technical Documentation, ISO 14971, UK MDR, EU MDR, Design Controls or validation activities would be advantageous. Excellent stakeholder management and communication skills. Please note: sponsorship is not available ...

development this cutting-edge medical device. Ideally, you will have worked within the Biotech or Medical Devices sectors previously and have knowledge of ISO 13485, IEC 62304 and ISO 14971. The company has the unique ability to offer an excellent benefits package, pension, medical insurance, life assurance ...

electromechanical machinery. Technical Basics: Familiarity with 3D CAD, electrical schematics, and industrial sensors/actuators. Bonus Points: Exposure to medical device/biotech standards (ISO 13485), basic robotics, or precision fluid handling. ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

electronics, you can demonstrate significant industry experience in electronic hardware design including prototyping, ECAD, test and manufacturing. Project experience with medical device regulations (ISO13485). Other highly-regulated industry experience may be considered. Experience with FPGAs or Python for test automation would be desirable. Exposure to optics, embedded software ...

site. Liaison with Fitters and Test Engineers. Building prototype assemblies. Meet appropriate company, national and international standards in product design, e.g., ISO61010, ISO13485, 21CFR820 etc. To keep up to date with available third-party components. To keep up to date with design techniques of analogue and digital circuits as well ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

device experience advantageous Project management experience beneficial High-speed PCB design Embedded systems and firmware development Desired PLCs EMC, LVD and RED IVDR/ISO 13485 Machinery Directive experience Company Information My client is a market-leading manufacturer continuing to invest in new product development and growth. They ...

mission-critical or highly regulated software . Desirable Skills & Experience Experience developing medical devices or other safety-critical systems . Knowledge of IEC 62304 , ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

safety-critical, mission-critical or highly regulated software. Desirable Skills & Experience Experience developing medical devices or other safety-critical systems. Knowledge of IEC 62304, ISO 13485 or similar regulated software development standards. Experience with medical alarm systems or other alarm and fault-management systems. Understanding ...

liaise with suppliers, Fitters and Test Engineers. You should be comfortable building, evaluating and testing prototypes, and working to the appropriate standards (ISO61010, ISO13485, 21CFR820). Experience/Qualifications/Skills: BSc/BEng degree in Electronics (or equivalent) Demonstrable experience in the development of scientific instrumentation or medical devices ...

others Commercial awareness and experience managing budgets and financial performance Experience of regulatory requirements and awareness of Governance Risk and Compliance Commercial experience of ISO 13485 is highly desirable All candidates applying must be eligible to work in the UK without sponsorship. Spectrum IT Recruitment (South) Limited ...