20 of 20 ISO 13485 Jobs in the UK excluding London

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 ...

assays and how to deliver products to manufacture. Strong communications skills for stakeholder collaboration, technical leadership and mentorship. Familiarity with relevant industry standards including ISO 13485, ISO 14971, 21CFR part 820 and MDR. This is a senior, technical lead role with expectations of hands-on experience. Projects … projects allow). Some international travel would be required for client visits. Keywords: Applied Life Sciences, Systems Engineering, PoC, In Vitro Diagnostics, Instrumentation Development, ISO 13485, ISO 14971, Technical Leadership, Mentoring, Commercial Aptitude, Consultancy, Cambridge/Hybrid Another top job from ECM, the high-tech recruitment experts. ...

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 ...

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 ...

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 ...

also possess previous experience in: Hands-on experience with machine shop tools and prototyping Experience with cleanroom-compatible machine design. Understanding of FDA regulations, ISO 13485, and equipment validation practices. Familiarity with MES and SCADA integration. Knowledge of lean manufacturing and Six Sigma principles. Radiometer, a Danaher operating ...

development this cutting-edge medical device. Ideally, you will have worked within the Biotech or Medical Devices sectors previously and have knowledge of ISO 13485, IEC 62304 and ISO 14971. The company has the unique ability to offer an excellent benefits package, pension, medical insurance, life assurance ...

electromechanical machinery. Technical Basics: Familiarity with 3D CAD, electrical schematics, and industrial sensors/actuators. Bonus Points: Exposure to medical device/biotech standards (ISO 13485), basic robotics, or precision fluid handling. ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

software for medical devices or another regulated industry, such as aerospace or automotive safety Working knowledge of relevant standards and regulatory frameworks, such as ISO 13485, IEC 62304 and IEC 60601, or equivalents A strong understanding of the documentation, traceability and verification required for safety-critical software Experience ...

similar CAD tools. Background in electromechanical, mechatronics, electronics or biomedical engineering. Practical, hands-on approach to design, testing and problem-solving. Experience with ISO 13485 or similar quality systems. ...

similar CAD tools. Background in electromechanical, mechatronics, electronics or biomedical engineering. Practical, hands-on approach to design, testing and problem-solving. Experience with ISO 13485 or similar quality systems. ...

similar CAD tools. Background in electromechanical, mechatronics, electronics or biomedical engineering. Practical, hands-on approach to design, testing and problem-solving. Experience with ISO 13485 or similar quality systems. ...

electronics, you can demonstrate significant industry experience in electronic hardware design including prototyping, ECAD, test and manufacturing. Project experience with medical device regulations (ISO13485). Other highly-regulated industry experience may be considered. Experience with FPGAs or Python for test automation would be desirable. Exposure to optics, embedded software ...

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 ...

device experience advantageous Project management experience beneficial High-speed PCB design Embedded systems and firmware development Desired PLCs EMC, LVD and RED IVDR/ISO 13485 Machinery Directive experience Company Information My client is a market-leading manufacturer continuing to invest in new product development and growth. They ...

liaise with suppliers, Fitters and Test Engineers. You should be comfortable building, evaluating and testing prototypes, and working to the appropriate standards (ISO61010, ISO13485, 21CFR820). Experience/Qualifications/Skills: BSc/BEng degree in Electronics (or equivalent) Demonstrable experience in the development of scientific instrumentation or medical devices ...

others Commercial awareness and experience managing budgets and financial performance Experience of regulatory requirements and awareness of Governance Risk and Compliance Commercial experience of ISO 13485 is highly desirable All candidates applying must be eligible to work in the UK without sponsorship. Spectrum IT Recruitment (South) Limited ...

ensure the smooth transition from design to production (DFM). ·Ensure the engineering function adheres to our relevant quality standards (IPC610, AS9100 and ISO13485). ·Lead from the front, identify and solve problems whilst remaining hands-on. YOUR BACKGROUND: Engineering Manager/Head of Engineering - Design Electronics Manufacturing As your … following products and/or services: engineering manager, technical manager, design, product development, PCB, electronics, production engineering, electronic design, simulation, FPGA, EMC, IPC610, AS9100, ISO13485, project engineer, project management, EMS, SMT, surface mount INTERESTED? Please click apply. You will receive an acknowledgement of your application. Wallace Hind Selection, alongside ...