1 to 25 of 87 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 ...

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 ...

help ensure that our software design and development activities meet global medical device requirements, leading the practical implementation of IEC 62304 (software lifecycle), ISO 14971 (risk management), and ISO 13485 (quality management systems) within an agile, iterative environment. You’ll help shape how design inputs, verification, validation … Medical Device Design Control Processes Lead the implementation and continuous improvement of design control processes across the software lifecycle in alignment with IEC 62304, ISO 14971, and ISO 13485. Partner with engineers and product managers to ensure requirements, risk controls, verification, and validation activities are clearly defined, documented ...

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 ...

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 ...

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 ...

lines Own spare parts forecasting and inventory for the service operation Ensure service records, complaint handling, and repair documentation meet our quality system requirements (ISO 13485) Report on service metrics: turnaround time, repair volume, failure trends, cost per repair - and feed failure data back to engineering What … repair Experience writing technical documentation in a regulated environment - service procedures, work instructions, SOPs - and participating in CAPA and nonconformance processes Working knowledge of ISO 13485 quality system requirements as they apply to service and repair Systems thinker: you see a pile of repairs and want to build ...

scratch, reporting directly to the technical lead. What you'll be doing: Developing and maintaining Embedded C firmware on STM32 Working within an ISO 13485/IEC 62304 regulated environment Getting to grips with (and improving) a Legacy codebase Helping shape the project scope and timelines from … start What they're looking for: Strong Embedded C on ARM microcontrollers, ideally STM32 Hands-on experience of IEC 62304 and ISO 13485 Keil experience is a bonus Bonus points if you've got opinions on how AI coding tools fit into Embedded work The project is still ...

tools in daily workflow. Strong understanding of clinical workflows, interoperability patterns, and NHS technical constraints. Experience with regulated healthcare or medical device software (ISO 13485, ISO 14971, IEC 62304). Experience with national NHS APIs such as GP Connect, PDS, PDM, SCR, or BARS referrals. ...

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 ...

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 ...

churned win-back. Complaint handling: Own the customer complaints procedure, built with our Regulatory team to align with our quality management system and ISO 27001. Make sure every complaint is logged, resolved within target and analysed for root causes. Team leadership: Line manage, coach and develop the Customer Success … success platforms and CRM tools, such as Custify, HubSpot or Airtable. Experience of complaints handling within a regulated or quality-managed environment, such as ISO 13485 or ISO 27001. Experience building or scaling a Customer Success function in a growing company. Benefits Competitive Salary Company Pension ...

automated tests. Nice to have (but we can teach you) Experience in working within a regulated SSDLC process Experience in working in MedTech, including ISO 13485 and ISO 62304 Benefits Competitive salary Share options package - all our employees have ownership in the company Private healthcare Company pension ...

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 ...