1 to 25 of 58 Permanent ISO 13485 Jobs in England

Ideally, the Medical Devices company you have worked for has produced handheld or portable Medical Devices, but as long as the device is to ISO 13485 standards, we will consider your allocation. You will be rewarded with an excellent starting salary and package while being a part of 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 ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view 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 ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

Would you like to be part of a team helping to create something truly ground-breaking and game changing in the medical device industry? We have a world class diagnostic technology that enables rapid detection of respiratory viruses such as 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 ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

Instructions and Standard Operating Procedures (SOPs). Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch. Ensure compliance with ISO 13485/FDA regulatory requirements. Qualifications … To be successful in this role, you should have: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment. Experience in writing test protocols aligned with Product Requirement Specifications. A degree in Science or Engineering or equivalent relevant experience. Experience … in medical device development and commercialization. Preferred Skills Hands-on experience in an ISO13485/FDA regulated environment. Strong background in developing and executing verification and validation protocols. Ability to collaborate effectively with cross-functional teams. Apply now as interviews are already being scheduled 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 ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

Hands-on experience in electronics development within In Vitro Diagnostic (IVD) devices or a similar highly regulated industry. Strong understanding of relevant standards, including ISO13485, IEC 61010, and IEC 60601. Experience with: Motor control, including stepper and DC brushed motors. Temperature control using resistive heaters and Peltier devices. Optical systems more »

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 »

s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

and developing a positive Quality culture within the organisation. Supporting all other departments to ensure they remain compliant to the accreditations. Primarily, the AS9100, ISO 9001, ISO 13485 (Medical Devices) accreditations for the Company and such other schemes or programs which arise through Customer or market needs … equivalent. Experience (minimum 2 years) in a quality position within a manufacturing/engineering environment. Experience working within one of the following regulated industries: ISO 9001, AS 9100, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in 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 »

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 »

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 »

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 »

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 »

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 »

. 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 »

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 »

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 »

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 »