20 of 20 ISO 13485 Jobs in England

image analysis to strengthen assay scoring and interpretation; evaluate emerging digital capabilities to expand our diagnostic toolkit. * Quality and Compliance: Embed CAP/CLIA, ISO 15189, ISO 13485, IVDR, HTA and HBS requirements in day-to-day practice, including SOP authorship, deviation/CAPA management, and audit … laboratory activities. * Experience of laboratory information systems (LIMS/LIS) and digital pathology. * Knowledge of relevant quality and compliance frameworks, including CAP/CLIA, ISO 15189, ISO 13485, ISO 14971, IVDR, HTA, and HBS, as applicable. * Experience with controlled documentation, including SOPs, deviations, CAPAs, and audit ...

Quality Supplier Officer, ISO 9001, Lead Auditing, Integrated Management Systems A Quality Supplier Officer opportunity has opened up with an established, family-owned business operating across multiple industries in the UK and beyond. This is a standalone role sitting within a dedicated QSHE team, offering genuine scope to shape … supplier approval and performance management programme, ensuring it remains aligned with the company's Integrated Management System and relevant certification standards including ISO 9001:2015, ISO 13485, ISO 14001, and others. On a day-to-day basis, you will plan and carry out external audits, both ...

corrective action investigations. Support the preparation of quality reports, KPI data and quality trend analysis. Quality Systems and Compliance Work in accordance with ISO 9001, ISO 14001 and ISO 45001, alongside any other relevant industry standards such as ISO 13485, AS9100 or IATF 16949. Ensure … specifications and work instructions. Competent in the use of inspection equipment such as calipers, gauges, microscopes and multimeters. Good understanding of quality principles and ISO standards. Strong attention to detail and a high level of accuracy. Good IT skills, including Microsoft Excel, ERP/MRP systems and quality databases. ...

analysis, and corrective/preventive actions. Collaborate effectively with production, engineering, and quality teams to ensure timely resolution of quality issues. Maintain compliance with ISO 13485 and other medical device regulatory standards. Contribute to Continuous Improvement efforts in Quality/Inspection processes and documentation. Increasing efficiency, improving … ability to interpret complex technical drawings and CAD data. Skilled in using a wide range of manual measurement tools. Familiarity with ISO 13485, ISO 9001, or other regulated quality systems. Good working knowledge of Quality documentation, including FAIRs, CTQs, inspection reports, NCRs, CAPA and Complaints. Strong teamwork ...

root cause activity, ensuring corrective actions address systemic causes rather than symptoms. Review production records and manufacturing documentation to ensure compliance with QSR and ISO requirements. Lead investigations into NCRs, CAPAs, complaints and manufacturing-related quality events. Audit manufacturing processes, internal systems and suppliers, translating findings into measurable process … operations. Experience & Technical Requirements Degree in Engineering, Science or a relevant technical discipline. 4+ years' experience within medical devices Strong working knowledge of ISO 13485, ISO 14971 and 21 CFR Part 820/QMSR requirements. Demonstrable experience in non-conformance investigation, root cause analysis, CAPA, risk management ...

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 13485certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied to software ...

technical leadership across software, embedded systems and connected technologies projects. Ensure software development activities comply with relevant quality and regulatory standards including IEC 62304, ISO 13485 and other applicable requirements. Drive and embed engineering best practice including code review, version control, CI/CD, automated testing and technical … Ability to coach, develop and inspire technical teams. Desirable Experience within medical devices, healthcare technology or other safety-critical industries. Knowledge of IEC 62304, ISO 13485, GMP and FDA-regulated environments. Experience with cloud platforms such as Azure, AWS or GCP. Understanding of cybersecurity for connected devices ...

service -- building and maintaining the in-house clinical and healthcare software that supports patient care across the Trust, all within the framework of an ISO13485-certified Quality Management System. This is a hands-on technical leadership role; therefore, if you love writing good quality code and also enjoy shaping … client and server environments Establishing and maintaining robust design, version control, and quality assurance practices for in-house systems, in line with the ISO 13485 QMS Designing, building, and supporting the data layer behind our clinical software, working across both relational and non-relational databases Troubleshooting complex software ...

tests Experience converting requirements into structured test cases and procedures Experience working with medical devices running embedded software Working knowledge of IEC 62304 and ISO 13485 Good understanding of the full software engineering lifecycle Able to work independently and self-manage a standalone testing function Desirable Knowledge …/or ISO 14971 Contract Details 6 month initial contract, with potential to extend 3 days per week onsite in Manchester Up to £425 per day, Outside IR35 How to Apply If you have embedded software V&V experience within a regulated medical device environment and IEC 62304/ ...

deliverables. Coordinate logistics for bench testing, pre-clinical work, and international clinical study site readiness. Regulatory & Quality Compliance • Ensure all development activities align with ISO 13485, FDA (510k), and MDR design control requirements. Structure project activities to generate robust design verification and validation (V&V) evidence. Support document … device development. Track Record: Proven history of driving Class II/III medical devices through to regulatory submission. Regulatory Knowledge: Strong working knowledge of ISO 13485, design controls, and FDA 510(k)/CE-mark pathways. Tool Proficiency: Mastery of planning tools such as MS Project, Smartsheet, Jira ...

Experience within precision engineering or regulated industries (medical device advantageous) Skilled in manual inspection techniques and measurement tools Familiarity with quality systems such as ISO 13485 or ISO 9001 Experience with quality documentation (FAIRs, NCRs, CAPA, etc.) Strong attention to detail and problem-solving mindset Good communication ...

patient safety principles An appreciation of electronics and hardware integration, beneficial rather than essential Familiarity with medical device standards and regulated pathways, for example ISO 13485, IEC 62304, ISO 14971, IEC 60601 and IEC 62366 Just as important as the person This is the part that will ...

Quality Assurance within the medical device industry. Strong knowledge of medical device design, development and Quality Management Systems (QMS). Working knowledge of ISO 13485, FDA 21 CFR Parts 820 & 11, and EU MDR (2017/745). Experience leading internal, external and regulatory audits. Understanding of risk … management principles (ISO 14971 desirable) and regulatory compliance requirements. Proven ability to lead CAPA and root cause investigations using recognised problem-solving methodologies. Experience driving continuous improvement and implementing quality improvement initiatives. Strong leadership, communication and stakeholder management skills, with the ability to influence cross-functional teams. Excellent analytical ...

similar tools. Working within regulated, compliance-driven environments. Highly Desirable Healthcare software experience. Medical device software experience. Software as a Medical Device (SaMD). ISO 13485 exposure. IEC 62304 exposure. Validation and verification (V&V) activities. Audit-ready documentation and traceability management. ...

maintaining Quality assurance processes Ensure efficient, effective and compliant QMS process Overseeing compliant investigations, internal audits and change management Look to maintain the ISO13485 certification Experience or Qualifications – Quality Assurance Manager Degree educated in a relevant subject associated to engineering, medical technology or equivalent Knowledge of ISO 13485 ...

manufacturing setting. Strong attention to detail and documentation skills. Understanding of regulated environments such as Medical Devices, Life Sciences, Pharmaceuticals, GMP, or ISO 13485 would be highly advantageous. Experience with incoming inspection, release testing, or supplier quality processes is desirable. This is an excellent opportunity for someone looking ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

devices or another regulated industry (e.g. aerospace, automotive safety, or similar safety-critical sectors) Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304, IEC 60601, or equivalent A strong grasp of the documentation, traceability, and verification rigour required for regulated, safety-critical software ...

defining and driving the software quality strategy, maintaining quality documentation, and ensuring that software development processes and verification activities comply with industry standards, including ISO13485 and IEC62304. The work of a successful candidate will be instrumental in ensuring the delivery of safe, reliable, and compliant software products. A suitable candidate … will have experience ensuring software development activities comply with relevant regulatory standards, including ISO13485 and IEC62304. A strong software engineering background is required as it brings practical insight into the software development lifecycle and helps shape effective, pragmatic quality processes that support both compliance and innovation. This is a fantastic ...

Ability to read simple electrical/fluid schematics and use hand tools Some soldering to IPC level manual/low volume machining light fabrication ISO EN 13485 We’re looking for individuals with curiosity, structured thinking, and the confidence to improve procedures— not just maintain them. Why Apply ...