26 to 50 of 60 ISO 13485 Jobs in the UK

Prototyping : Hands-on experience with miniaturization, waterproofing, and creating robust electronics for wearable devices. MedTech Regulatory Standards : Knowledge of medical device regulatory standards (e.g., ISO 13485, FDA) and experience in compliance testing. Sensor Integration : Familiarity with various biosensor technologies, including electrochemical sensors used in wearable health devices. Wearable More ❯

the business working closely with staff at all levels of the organisation. You will take a prominent role leading/driving internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the quality team that need to be delivered … or pharmaceutical Quality Assurance, Senior Quality Assurance, Principal Quality Assurance Engineers or QA Specialists. All candidates should have strong experience leading or closely supporting ISO13485/MHRA audits, driving QA projects across a business and leading/coaching/mentoring junior colleagues in the QA function. Exposure to leading or More ❯

Python applications for medical device software Collaborate with cross-functional teams, including R&D, product management, and QA Ensure software meets regulatory standards (e.g., ISO 13485, IEC 62304) for medical devices Write clean, efficient, and well-documented code following best practices Participate in code reviews, testing, and continuous More ❯

all Supplier generated design changes are managed and documented in a compliant manner. Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 13485 requirements during day to day and assigned audit/CAPA activities. Maintain a good level of housekeeping in designated areas and observe … experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong … sound judgment is highly desired. Understanding of the NPI (New Product Introduction) process and Process Validation is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required. Demonstrated project management and project leadership abilities. Rewards & Benefits TCS More ❯

role in the business working closely with staff at all levels of the organisation. You will take a prominent role across internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the broader quality team that need to be … are looking for an experienced medical device, life sciences or pharmaceutical Quality Assurance Engineer or Quality Assurance Specialist. Candidates should have some experience supporting ISO13485/MHRA audits, contributing to QA projects across a business and possess good generalist QA and some QC experience. Exposure or knowledge of FDA accreditation More ❯

medical device,pharmaceutical or similarregulated sectors with a Total Quality Management approach. - Experience in the application and management of Quality Management Systems to meet ISO 13485 and GMP requirements. - Ability to implement company systems, processes and policies with consistency, being a key presence on site championing quality assurance More ❯

noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯

noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯

noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯

both customer-provided and Plexus-developed test solutions. Defining and supporting calibration and preventative maintenance processes. Validating test systems/fixtures for compliance with ISO 13485 and FDA 21 CFR 820 standards. Performing failure analysis and yield improvement actions on PCBAs and complete end products. Utilizing problem-solving More ❯

of electronics and software development methodologies will be needed embedded systems with RTOS a plus. Youll ensure the project adheres to Regulations and Standards (ISO13485, IEC 62304, FDA, CE Marking, etc) and Quality, and will keep abreast of Project Risks, Technical Documentation, and Project Tasks/Milestones. As well as More ❯

such as PyTorch or TensorFlow. Familiarity with FDA regulatory pathways for medical software (e.g., 510(k), De Novo), and standards like IEC 62304 or ISO 13485. Experience with MLOps practices and model versioning in compliant environments. Preferred Qualifications: Experience building ML models with wearable data (e.g., continuous heart rate More ❯

and third parties to maintain and improve product quality. Key Responsibilities: Take full responsibility in maintaining the Quality Management System (QMS) ensuring compliance with ISO 13485. Ensure that technical documentation (where appropriate) conforms with audit requirements. Manage documentation and reporting for non-conformances (NCR), deviations and complaints. Act as … all team members. Experienced required: previous experience of Quality Management/Quality Assurance Management in a fast-paced manufacturing environment (Essential). Knowledge of ISO 13485 (Desirable). Experience of working with regulatory bodies. Hands-on problem-solving skills with a focus on efficiency and quality. Excellent computer More ❯

Hands-on with frameworks like PyTorch , TensorFlow , MONAI , nnU-Net , etc. Experience with DICOM data handling Bonus points for any exposure to regulatory standards (ISO 13485, FDA SaMD) or experience in clinical AI validation MSc, PhD, or equivalent industry experience in AI, Computer Vision, or Biomedical Engineering Why More ❯

Hands-on with frameworks like PyTorch , TensorFlow , MONAI , nnU-Net , etc. Experience with DICOM data handling Bonus points for any exposure to regulatory standards (ISO 13485, FDA SaMD) or experience in clinical AI validation MSc, PhD, or equivalent industry experience in AI, Computer Vision, or Biomedical Engineering Why More ❯

existing software in line with defined procedures. Ensure all activities undertaken are in compliance with company SOPs and Work Instructions and in accordance with ISO 13485 and CFR 820. Ensure the Service Desk Team Lead is made aware of key support issues and trends identified in the ITSM. More ❯

role with an innovative, growing company? Do you have experience with coordinating internal and external audits? Have you worked to industry standards such as ISO13485, AS9100 and ISO9001? If so, this Quality Systems Engineer position is perfect for you! This Quality Systems Engineer is working for an electronics manufacturer in More ❯

can present experimental results to a range of stakeholders. Additional experience in the following is an advantage: Experience working within a regulated industry, especially ISO 13485. An interest in programming and data automation. Background in designing and testing sealed fluidic plastic components. This is a fantastic opportunity for a More ❯

and testing across multidisciplinary technologies Supporting the development of a fully functional prototype for clinical use Applying engineering best practices and design controls under ISO 13485 Bridging the gap between concept, prototype and production Collaborating with internal teams and external suppliers to get the product right We are More ❯

and testing across multidisciplinary technologies Supporting the development of a fully functional prototype for clinical use Applying engineering best practices and design controls under ISO 13485 Bridging the gap between concept, prototype and production Collaborating with internal teams and external suppliers to get the product right We are More ❯

e.g., MATLAB, Python) Experience architecting complex medical or diagnostic devices, working across hardware, software, and mechanical disciplines Familiarity with regulatory and compliance frameworks (e.g., ISO 13485, IEC 60601, FDA QSR) Understanding of design verification, validation, and risk management processes Practical knowledge of design-for-manufacture and design transfer More ❯

manual and automated testing, with knowledge of leading QA tools and frameworks. Experience working in regulated environments (e.g., digital health, SaMD) and familiarity with ISO 13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯

e.g., MATLAB, Python) Experience architecting complex medical or diagnostic devices, working across hardware, software, and mechanical disciplines Familiarity with regulatory and compliance frameworks (e.g., ISO 13485, IEC 60601, FDA QSR) Understanding of design verification, validation, and risk management processes Practical knowledge of design-for-manufacture and design transfer More ❯

manual and automated testing, with knowledge of leading QA tools and frameworks. Experience working in regulated environments (e.g., digital health, SaMD) and familiarity with ISO 13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯

Engineering, or a related engineering field. At least 5 years' experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485. Experience developing products in an IVD diagnostic development, including the use of statistics in experimental design. Strong understanding of mechanical, electronic, and software More ❯