Newcastle, Staffordshire, West Midlands, United Kingdom
The Electronics Group Ltd
quality assurance activities including root cause analysis and quality improvement. Main responsibilities: Maintain and enhance the Quality Management System (QMS) to ensure compliance with ISO 9001, AS9100, ISO13485, and other relevant standards. Facilitate, control, and conduct internal audits to ensure continuous compliance and improvement. Assist in … with Root Cause Corrective Action investigations, 8D problem solving techniques and Failure Mode Effect Analysis (FMEA) processes. Experience in auditing and maintaining compliance with ISO standards such as ISO 9001 (AS9100, ISO13485, IPC610 & IPC620 desired but not essential) Strong skills in customer interaction and managing more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO13485ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we more »
support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … to urgently and accurately perform all operations required during a pharmaceutical recall. Key Skills/Experience/Requirements: Good knowledge of GDP and the ISO 9001 standard, understanding of ISO13485 would be an advantage. Eligibility to become GDP Responsible Person and Responsible Person for Import. Good more »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
identification. Conduct quality audits across all organisations. Performance Measures: Maintain documented quality systems across the group. Support internal and external audits for compliance with ISO13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other regulations. Prepare and maintain QMS and … documentation. Assist QA Admin team with product approvals for UK and international markets. Evaluate suppliers and conduct approval audits. Document quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and non-conformance investigations. … Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO13485 and global device directives/regulations. Maintain technical/design history files for compliance. Medical experience in a production/manufacturing environment. Internal and external quality auditing experience more »
CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO13485, ISO 14708, and other relevant medical device standards. What Sets This Role Apart: Collaborate with top minds in an innovative, ethical more »
Petersfield, Hampshire, South East, United Kingdom
Bennett and Game Recruitment LTD
including creating and implementing test plans. Maintain an appropriate working knowledge of medical standards including but not limited to IEC 60601-1 Ed 3; ISO 14971; IEC 62366; ISO 62304; ISO13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of more »
development to launch and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »
candidates working in other areas of life sciences quality, such as Analytical Chemists, who seek a move into Quality Assurance! Experience of working to ISO 9001, ISO13485, 21CFR part 820 or EudraLex Volume 4, Part II. On this occasion, LiCa Scientific is acting as an employment more »
Chesterfield, Derbyshire, East Midlands, United Kingdom
Great Bear
Operative you willbe responsible for the day to day quality administrative tasks and supporting the department to ensure that the business is compliant to ISO 9001, ISO13485 and GDP requirements. Job responsibilities of a Quality Assurance Operative include: Record and distribute meeting minutes Ensure calibration records more »
of continuous improvement. Provide training and support to staff on GDP compliance and quality assurance processes. Required Skills: Solid understanding of GDP regulations and ISO 9001 and ISO13485 standards. Proven experience in a quality assurance role, preferably within the distribution, logistics, or pharmaceutical sector. Exceptional attention more »
Leighton Buzzard, Bedfordshire, South East, United Kingdom
Polar Speed Distribution Ltd
the Head of QA and responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 standards, and in compliance with EU GDP guidelines. In addition to this you will initiate and attend regular QualitySystem Management Review meetings, and … Key Skills/Experience/Requirements: Successful candidate MUST be eligible to become a Responsible Person for Import. Exceptional knowledge of GDP and the ISO 9001 standard, understanding of ISO13485 would be an advantage, good knowledge of Microsoft Office, Excel, Power Point Good communication skills to more »
Royston, Hertfordshire, Melbourn, Cambridgeshire, United Kingdom
Polytec Personnel Ltd
At least 5 years' experience in developing software and troubleshooting hardware issues * Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304 * Significant experience in formal software verification * Proficiency in C/C++ programming languages * Experience with Real-Time Operating Systems and bare-metal development more »
Royston, Hertfordshire, South East, United Kingdom
Oho Group
software for their advanced diagnostic systems, collaborating closely with internal and external software teams. Role requirements: Experience in regulated IVD development, including compliance with ISO13485 and IEC62304. Significant experience in formal software verification. Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »
Cambridge, Cambridgeshire, East Anglia, United Kingdom
Oho Group
and resolve issues. Perform formal software verification. Qualifications To succeed in this role, you should have: Experience in regulated IVD development, including compliance with ISO13485 and IEC62304. Significant experience in formal software verification. Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »
previous experience within a senior buying role is required. Experience of working according to industry standards e.g., quality management systems such as ISO9001 or ISO13485 is essential. Working knowledge of appropriate regulations and good practices. Experience in regulated environment is an advantage (e.g. medical devices, pharma, aerospace) Person Specification Expertise more »
production process and creating quality checkpoints. Review batch records, ensuring error-free manufacturing and batch release, including improving batch record templates. Maintain compliance with ISO13485 and CFR Part 820 Support the implementation and ongoing management of an eQMS. Essential Skills & Experience Relevant engineering or science degree and/or relevant … etc. Desirable Skills & Experience Previous experience of working with electronic components Experience in Quality Control function such as inspection and measurement. An understanding of ISO13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements. Person Specification With previous experience as a Quality Engineer in manufacturing within a more »
processes including injection moulding, machining and fabrication Depth of knowledge of manufacturing processes (for plastic/metal) and its design requirements Strong knowledge of ISO13485 or other quality management systems Ideal but not compulsory: Medical device development experience Project management experience Understanding of electrical engineering integration Consultancy experience Please attach more »
Maidstone, Kent, South East, United Kingdom Hybrid / WFH Options
Bedfont Scientific Ltd
usability engineering processes (with IEC 62366-1/FDA guidelines) to ensure safety and efficacy of medical devices for end-users Ensure adherence to ISO13485 standards (training will be provided) Complete the testing section of technical files prior to product launch Articulate comprehensive justifications for determining sample … assurance preferred Experience leading a small team would be advantageous Knowledge of industry standards and regulations related to V&V processes preferred, such as ISO standards, FDA regulations (for medical devices) Valuable Expertise: Leadership skills to coordinate a small team Detail orientated and analytical thinker to quickly detect issues more »
Experience of both quality management systems and complete engineering lifecycles and processes, along with an understanding of Medical Device Regulation (MDR) requirements, together with ISO13485, FDA Design Control and 510k submissions would be beneficial Desirable Experience/Qualifications: Knowledge/understanding of plastic injection moulding Experience of more »
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
Oxford, Oxfordshire, South East, United Kingdom Hybrid / WFH Options
Orion Electrotech Sales
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up more »
South West London, London, United Kingdom Hybrid / WFH Options
Austin Vita
reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »
expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »