1 to 25 of 59 ISO 13485 Jobs in England

industry. - Familiarity with ISO 9001, ISO 13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might be? Reach out to ­­­­Ben Godley using the following: ✉️ 📞 01892 362010 Apply now: If more »

Experience working with early-stage products. Experience developing approval ready devices and products. Experience with C++ & C also useful. Experience within Medical Devices Sector (ISO 13485). If interested, please apply, or reach out for further information about the role more »

all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »

. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »

into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO 13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »

regulatory processes are followed meticulously. Report any QC pass and fails, monitoring any non-conformance closely and taking corrective action. Strictly adhere to all ISO 13485/FDA regulations. Follow SOP’s, maintaining accurate records and document all production activities in accordance with company policy. Your background: BSc … or equivalent in a Biological discipline (or related). Background in an IVD development setting, working to ISO 13485 standards in a production or QC team. Proven industry/commercial lab experience, ideally where there are devices in development. Good proficiency with RT-PCR along with other classic more »

Minimum of 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 (RTOS) and bare-metal more »

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; ISO 13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of 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 »

laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »

PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards Industry experience in a Quality role and in a Senior Leadership position (department head) Experience of running a medium-sized Life Science organisation Well more »

and Heidenheim controls. ?Undertake tool changes, offsets, and program editing ?Produce components to production deadlines ?Work to tight tolerances and strict quality standards (AS9001 & ISO 13485) ?Working a rotational shift of earlies and lates as follows: o6am - 2 Mon - Thurs, 12.30 finish on Fridays o2pm to 12.30 Mon more »

Experience/Qualifications : Experience within the medical device industry, with knowledge of MDD 93/42/EEC, EU MDR (2017/745) and ISO 13485 is desirable Experience working with technical documentation and data management Experience working on multiple projects simultaneously Key Skills: Excellent technical reading comprehension … Assurance, Quality Assurance Coordinator, QA Coordinator, Health and Safety Officer, Audit, Medical Compliance, MDD 93/42/EEC, EU MDR (2017/745) ISO 13485 etc REF more »

you also have experience managing a small team of Quality Engineers, please read on! Main tasks and area of expertise: Maintaining the MDSAP and ISO 13485-certified Quality Management System. Ensure all procedures are up to date with changing standards and regulations and are being implemented by all … employees. Supporting the management of the Information Security Management System alongside the Information Security Officer (as per ISO 27001). Facilitate management reviews, notified body audits, supplier audits, and internal audits. Essential Prior experience of working for a small to medium-sized medical device company in quality or compliance … medical device regulations). External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments. Knowledge of quality standards including ISO 13485 and ISO 14971 Advantageous Qualification in regulatory affairs or quality assurance Knowledge of MDSAP regulations If this sound like a good more »

Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits 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 (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »

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 »

development, detailed design, and design for manufacture for: medical and diagnostic devices, consumer personal electronics devices 3. Awareness of medical device processes and standards (ISO13485, 62304, 60601) 4. Experience in designing proof of concept (PoC) systems using Python/MATLAB and microcontrollers 5. Knowledge of machine learning and AI 6. more »

activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering more »

report Skills and experience required: + Degree in relevant discipline + Proven experience in medical device development + Previously worked to relevant quality standards – ISO 13485 + Experience in prototyping and testing + Strong 3D CAD skills + Experience in different manufacturing processes - injection moulding The salary will more »

and supporting the operation in the maintenance of quality. Maintaining a thorough working knowledge of practices, procurement, licensing, and regulatory requirements (IVDR, UK MDR, ISO13485) in all areas associated within Pathology and in particular relating to design, development, manufacture and testing of NHSBT produced reagents. Having expert knowledge in in more »

Test Engineer Petersfield GU32 £17.00p/h We are recruiting for a Test Engineer for one of our clients based in Petersfield. The company is a family run company that work on medical and defence equipment. This is an ongoing more »

ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO 13485 ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we more »

ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO 13485 ISO (phone number removed) ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox more »

to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »