1 to 25 of 59 ISO 13485 Jobs in the UK excluding London

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 ...

during a scan. Following initial research-market sales, we are now progressing our technology toward release as a regulated medical device and building an ISO 13485-compliant design and development capability. Description of the role: As a Design Assurance Engineer, you will play a pivotal role in enabling … from user needs to V&V evidence. Participate in cross-functional design reviews to ensure documentation is audit-ready and technically sound. Risk management (ISO 14971): Drive and maintain risk management activities as designs evolve; ensure risk controls are implemented and verifiable; facilitate workshops/coaching where required. Usability ...

systems. Lead firmware architecture, requirements definition, and design from early concept through product release. Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971. Act as the firmware compliance leader, guiding the team … experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages. Demonstrated experience working within an ISO 13485–certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied ...

full software development lifecycle, including requirements definition, architecture, implementation, testing, risk, cybersecurity and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, ISO 14971 and other relevant safety standards. Establish and enforce high-quality software design control practices, including code reviews. … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

technical consultancy environment, with direct responsibility for client relationships and expectations. Strong understanding of the product development lifecycle in a regulated environment ideally ISO 13485, from early concept and requirements to verification, validation, regulatory submission and transition to manufacture. Confidence working with technical specialists from different disciplines, with … minimum 2.1 in a degree or equivalent professional experience in engineering, physical sciences, product design or another relevant technical discipline. Working knowledge of ISO 13485 or comparable product-development quality frameworks Familiarity with medical device risk management, ideally ISO 14971. Experience managing medical software development projects, ideally ...

Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

Global Technology Team. This is a critical role within our orthopaedic medical device business, ensuring that software and system development processes comply with FDA, ISO and European Medical Device regulations and standards. What you’ll do: Software & System Quality Oversight Provide expert quality assurance guidance and oversight for software … Technology or a related discipline. Minimum of 5–7 years’ experience within Quality Assurance, Medical Devices and Software Development environments. Strong working knowledge of: ISO 13485 ISO 14971 IEC 62304 Experience supporting product and software development lifecycles. Knowledge of FDA regulations, including: 21 CFR Part ...

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. #J-18808-Ljbffr ...

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 ...

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 ...

component performance, ensuring all observations and data are recorded.Analysing results and experimental data to determine pass/fail. All activity to comply to ISO9001 & ISO 13485 (cGMP) Responsible to the Maldi Test Manager for: Final test of MALDI TOF instrument systems, checking their performance for reliability and specification … continuous improvements. When required, train new engineers and peers. Correct use of tools and processes, described in SAMI's & Test procedures. Comply to ISO9001 & ISO 13485 (cGMP) If required Commissioning of instruments within the U.K. and R.O.W. territories Qualifications (Essentials/Desirable): Degree/HND science/engineering ...

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 ...

your time to different locations mainly within Europe. Beneficial Qualifications: Familiarity with healthcare/MedTech software regulatory standards (IEC 62304, ISO 13485, ISO 14971, IEC 81001-5-1). Experience with threat modeling, secure data handling, design controls, and regulatory submission documentation. What we offer The opportunity ...

recruitment process, please let our recruitment team know. Sustainability & Privacy We are dedicated to our BZero sustainability roadmap (targeting SBTi net-zero) and hold ISO 14001, ISO 45001, and ISO 13485 certifications. By applying to this role, you are giving consent to Bespak Limited to process ...

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 ...

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 ...

need to succeed You will have: Previous Quality Engineering experience within medical devices or another highly regulated manufacturing environment Strong knowledge of ISO 13485 and medical device quality systems Experience managing non-conformances, CAPA and root-cause investigations Knowledge of quality tools such as 8D, 5 Why, Fishbone … Good knowledge of UK MDR and EU MDR, particularly Technical File generation, maintenance or remediation A relevant engineering, scientific or technical qualification Experience with ISO 14971, design controls, process validation, complaint handling, supplier quality or internal auditing would be advantageous. What you'll get in return You will receive ...

DevOps, Zephyr Experience in the use of automated test software tools such as Ranorex, Playwright, Selenium, Test Complete Knowledge of IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality systems and IEC 62366-1 usability engineering or comparable standards for other regulated sectors. #J ...

part of the role Experience of line management, supervision or mentoring of technical, manufacturing or workshop-based staff Desirable Criteria Experience of quality auditing, ISO 9001, 13485, or similar, supplier management, line management or regulated manufacturing environments Experience of CAD, rapid prototyping, product development and collaboration with design ...

technical stakeholders. Desirable Experience supporting software products through regulatory submissions, inspections, audits, or product approvals. Familiarity with standards and regulations such as IEC 62304, ISO 13485, FDA software guidance, EU IVDR, IEC 81001-5-1, or comparable industry frameworks. Familiarity with secure software development practices, vulnerability management, Software ...

Ranorex, Playwright, Selenium, Test Complete Ability to develop source code/scripts with at least one programming language. Knowledge of IEC 62304 software lifecycle, ISO 14971 risk management, ISO 13485 quality systems and IEC 62366-1 usability engineering or comparable standards for other regulated sectors. #J ...

team High attention to detail and ability to multi-task Initiative driven and deadline focusedCommitment to Health & Safety standards Performance Standards BS EN ISO 9001 – Quality Management Systems BS EN ISO 13485 – Medical Devices Quality Management IPC-A-610 – Acceptability of Electronic Assemblies AS9100 – Aerospace Quality Management ...

room HVAC system and all associated filtration and ducting to ensure the clean room remains compliant to ISO7 standard in accordance with BS EN ISO 14644. Recruit, train and mentor a small team of maintenance technicians, when required, to be competent in all clean room and equipment maintenance activities. … systems designed to function within an ISO7 clean room. Experience of working within an organisation certified to one or more of the following standards: ISO 9001, AS 9100, ISO 13485, IATF 16949. Proficiency in Microsoft Office (or equivalent), for using spreadsheets and generating written documents. Ability ...

layouts, assembly drawings, BOMs and work instructions. A good understanding of electronics manufacturing quality standards and processes . Ideally, experience working within an ISO 9001 and/or ISO 13485 environment. Excellent attention to detail and good manual dexterity when handling small electronic components. Basic ...