26 to 50 of 53 ISO 13485 Jobs in England

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

Systems Engineering or related engineering field. At least 10 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 use of Statistics in experimental design. Strong understanding of mechanical, electronic and software design More ❯

and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring More ❯

/or presentations at conferences Experience with data management, for example using Excel, R or SQL 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 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 … a full time on site role. The Quality Systems Engineer will support and develop the Business Management System, ensuring compliance with ISO9001, AS9100, and ISO13485 standards. Key responsibilities of the Quality Systems Engineer include document control, internal and external audit support and continuous improvement activities. The role involves coordinating external … ensuring effective system integration and compliance across operations. You will need: Experience with quality and business management systems Experience working to standards such as ISO13485, AS9100 and ISO9001 A background within manufacturing Internal auditing experience A degree or equivalent qualification in a relevant field is desirable Previous experience or knowledge More ❯

similar role. Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDR, MDSAP). Lead audit trained in ISO13485/9001 Proven experience in relevant areas of Quality, Regulatory, or Engineering, preferably within a medical device environment. Strong written and verbal communication skills and More ❯

Web Apps and Functions Implement logging, monitoring, and alerting solutions for security events and system health Automate compliance checks and documentation for ISO27001 and ISO13485 requirements Collaborate with development teams to implement security best practices and DevSecOps processes Manage and maintain security protocols for handling sensitive healthcare data Required Qualifications … Azure Web Apps and Azure Functions Deep understanding of cloud security best practices and implementing Zero Trust architecture Experience with healthcare compliance requirements (ISO27001, ISO13485, HIPAA) and security controls Proven track record implementing automated security testing and vulnerability management Strong knowledge of monitoring and observability tools (Azure Monitor, Application Insights More ❯

Web Apps and Functions Implement logging, monitoring, and alerting solutions for security events and system health Automate compliance checks and documentation for ISO27001 and ISO13485 requirements Collaborate with development teams to implement security best practices and DevSecOps processes Manage and maintain security protocols for handling sensitive healthcare data Required Qualifications … Azure Web Apps and Azure Functions Deep understanding of cloud security best practices and implementing Zero Trust architecture Experience with healthcare compliance requirements (ISO27001, ISO13485, HIPAA) and security controls Proven track record implementing automated security testing and vulnerability management Strong knowledge of monitoring and observability tools (Azure Monitor, Application Insights More ❯