26 to 49 of 49 ISO 13485 Jobs in the UK

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

a Quality Assurance Specialist to join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory, ISO, and client requirements. … Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. More ❯

maintaining a strong focus on customer satisfaction. Maintain organised records and ensure all documentation is archived in line with company policies. Follow all relevant procedures and quality standards, including ISO13485, ISO14001, and Medical Device Regulations. Engage in continuous improvement by completing all required training and Learning Management System (LMS) modules on time. Qualifications and Experience: Must be educated to a … at least 2 years' proven experience in a similar role. Excellent communication skills (written and verbal). Experience with SAP and Salesforce is highly desirable. Experience working in an ISO 13485 , 14001 and MDR regulated environment is desirable. Skills: IT Skills including the ability to use Microsoft Office at a proficient level. Good English in verbal and written More ❯

to work in the UK Genedrive is a pioneering medical device company headquartered in Manchester, focused on developing innovative molecular diagnostic solutions that improve patient outcomes worldwide. Certified to ISO 13485:2016 and operating in compliance with BS EN ISO 14971 and IEC 62304, Genedrive is dedicated to meeting the highest standards in medical technology. With a … Degree-qualified in a science or engineering discipline Minimum 3 years of experience in a QA/RA role within the IVD or medical device sector Solid understanding of ISO 13485 and ISO 14971 Experience with internal/external audits and training delivery Excellent analytical, organisational, and communication skills Comfortable working independently and within cross-functional teams … Desirable: Knowledge of IEC 62304, ISO 60601, and global radio regulations Experience with global medical device regulations particularly UK, EU and USA Familiarity with the commercialisation of IVD products ISO 13485:2016 Lead Auditor training This role is a unique chance to step into a high-impact position within a fast-moving and rewarding sector, apply now More ❯

manage a career development framework. Own IEC 62304 traceability, architecture documentation, and release quality for critical features and audits. Establish agile delivery practices that work within the constraints of ISO 13485 and MDR/FDA expectations. Introduce best engineering & delivery practices, improve and and report on velocity, release cadence, defect rate, and other metrics. Champion continuous improvement - lead … paced, regulated medical or AI-based software environment, having delivered multiple health tech products Building and delivering clinical software products with end-to-end traceability under IEC 62304 and ISO 13485 Driving complex technical decision-making (e.g., architecture reviews, release criteria) Leading or supporting regulatory audits and inspections Managing stakeholders across Engineering, Product, QA, and Compliance Implementing metrics … team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

you must be able to attend the Trust Hospital site in person** Main duties of the job The Quality & Information System Manager is responsible for the Clinical Engineering Department ISO registration and ongoing compliance as well as the databases used within Clinical Engineering. Responsible also for co-ordinating the training programmes for ISO and databases for all clinical … on one of the Trust sites Mon-Fri, with the occasional service need to work out of hours.o To maintain comprehensive training records for clinical engineering personnel relating to ISO and the databases.o To organise and co-ordinate internal/external training programmes for clinical engineering personnel.o To assist the senior management team in maintaining the departments database and … ISO 13485 Quality Management System (QMS) ensuring all associated paperwork is maintained and current.o Main site of work is at University Hospital Lewisham, but the post holder may also be required to start work on any site used by the Trust. Travel between sites may be required within a working day, for example to travel between University Hospital More ❯

skills * Great attention to detail and a results driven approach * Excellent organizational and leadership abilities * Reliable and Trustworthy * Certification of quality control is a strong advantage (ISO 9001, ISO13485 etc.) Please send your CV to me, Martin Warner, and I will get back to you as soon as possible More ❯

pragmatic, can-do attitude Comfortable working across teams in a fast-moving, multidisciplinary environment Well-organised, detail-oriented, and driven to see complex projects through to completion Experience with ISO 13485 or similar regulated manufacturing is a big plus Who you'll work with: Our Director of Cartridge Manufacturing and Programme Managers Cross functional teams including engineers, technicians More ❯

Requirements: 2 3 years experience in sales or business development within electronics Demonstrable success in driving new business Excellent communication and negotiation skills Familiarity with ISO9001 and/or ISO13485 Full UK driving licence Ability to travel to East Kent 3 times per week Looking for a role where you can make a real impact? Apply now. Morgan Jones is More ❯

to continual process improvement across the business. Responsibilities as a Quality Systems Engineer in Andover. Develop and maintain the Business Management System and supporting software platform. Ensure compliance with ISO 9001, AS 9100, ISO 13485, and related standards. Conduct investigations using 8D, Ishikawa, and 5WHY methodologies. Lead or support internal audits and prepare for certification, regulatory, and … system performance. Requirements as a Quality Systems Engineer in Andover. 3+ years of experience in quality management within manufacturing or product development. Strong working knowledge of ISO9001, AS 9100, ISO13485, and ISO14001. Degree in Electrical or Mechanical Engineering (or equivalent experience). If you are interested in this Quality Systems Engineer job in Andover. then APPLY NOW. More ❯

UK. Job description Job responsibilities DUTIES AND RESPONSIBILITIES General Ensure all work complies with current UK legislation for work with ionising radiation (IRR 2017, IRMER 2017) and the Trusts ISO 9K2K-compliant quality management system for provision of radiotherapy. The post holder will be expected to prioritise and manage their own work on a day-to-day basis. The … Knowledge Essential oKnowledge of radiotherapy physics oUnderstanding of the role of computational systems in radiotherapy oKnowledge of relevant legislation, national standards, and professional guidelines (e.g. IRR'99, IRMER 2000, ISO:9K2K, ISO 13485, ISO 14971, IPEM Codes of Practice, GDPR, Data Protection Act) Desirable oTheoretical Machine Learning/AI and statistics knowledge oUnderstanding of principles of More ❯

through certification under UK MDR You're highly self-starting, proactive, and comfortable working autonomously You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485 You've worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development You're More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

company's solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for We are looking for Salesforce Implementation to become an integral part of our Professional Services team at Dot More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

worker with a flexible schedule and a commitment to excellence. Full UK driving licence and a readiness to travel regularly across the UK. Familiarity with quality standards such as ISO 13485 or CE/UKCA is a plus. What's on Offer A highly competitive salary tailored to your experience and expertise. Performance-based bonus structure to reward More ❯

and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Technical knowledge (platform/backend) is advantageous Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

MDR would be advantageous. Previous medical device experience is a bonus. Clear communication skills. Comfortable in dealing with triage clinical queries. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS). We require that our More ❯

looking for: Strong attention to detail and a systematic approach to tasks Excellent written and verbal communication skills Experience handling components and sub-assemblies Awareness of quality systems (ISO9001, ISO13485 or similar) is a plus Computer literacy and confidence working with documentation systems In return you will receive a salary of up to £25,000 per annum, depending on skills More ❯

looking for: Strong attention to detail and a systematic approach to tasks Excellent written and verbal communication skills Experience handling components and sub-assemblies Awareness of quality systems (ISO9001, ISO13485 or similar) is a plus Computer literacy and confidence working with documentation systems In return you will receive a salary of up to £25,000 per annum, depending on skills More ❯

s revolutionising medical diagnostics and transforming patient care. Key Responsibilities Oversee and develop our medical device Quality Management System (QMS) and Information Security Management System (ISMS), ensuring compliance with ISO 13485, MDSAP, US FDA QSR, EU MDR and ISO 27001. Implement and secure certification for an Artificial Intelligence Management System in line with ISO 42001 and … or related field. Minimum 5 years of hands-on QMS management experience in medical devices, preferably with AI/Software as a Medical Device (SaMD) products. Demonstrable expertise in ISO 13485, EU MDR and FDA QSR (21 CFR 820) quality system requirements. Proven track record supporting external audits (notified body, FDA inspections). Experience leading significant management system … changes and improvements. Strong analytical and problem-solving skills, with ability to find pragmatic and creative solutions. Certification as a Lead Auditor (ISO 13485) and/or Certified Quality Auditor (CQA) is a plus. Competitive salary Share options package - all our employees have ownership in the company Private healthcare 25 days annual leave (+ company shut down in More ❯

Engineering, Computer Vision, or related field (or MSc + significant experience) Solid grasp of image segmentation, 3D data handling, and deep learning architectures Bonus: experience in regulated environments (e.g. ISO 13485, FDA) ✅ What’s On Offer High-impact work shaping the future of AI in healthcare Collaborate with exceptional talent in a mission-driven environment Flexible remote/ More ❯

trend analysis, clinical evaluation reports including literature search, post market clinical follow-up studies, and vigilance reporting. Regulatory & Medical Device Compliance Support compliance with UK MDR, EU MDR, and ISO standards (e.g., ISO 13485). Contribute to the preparation of regulatory submissions and audits by providing clinical evidence and safety documentation. Participate in internal and external audits More ❯

standards. It requires attention to detail, an analytical and structured approach, and a great ability to work with people across the business. You'd be responsible for: Knowing the ISO standards applicable to us (13485, 14971, 62304, 82304 in particular) and understanding how they map onto day-to-day Flok activities and tools. Helping us design, implement, and More ❯