1 to 25 of 85 ISO 13485 Jobs in the UK

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, ISO 13485, 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, ISO 13485, IPC610 & IPC620 desired but not essential) Strong skills in customer interaction and managing more »

internal audits and supplier audits as required Requirements: * Previous experience in Document control, quality assurance or similar * Experience working with QMS systems * Knowledge of ISO 13485 or ISO 9001 would be an advantage * Excellent attention to detail * Able to work as part of a team To be more »

improvement, contributing to continuous improvement initiatives. Qualifications, Skills and Abilities Essential: HND/Graduate level or previous experience in Quality Assurance role Understanding of ISO13485, ISO15189 or ISO9001 requirements Previous experience working with In Vitro Devices (IVD/IVDR) or Medical Devices (MDD/MDR) Attention to detail/concern more »

a proven background in In Vitro Diagnostics or Medical Devices. You will have strong experience in the management and/or implementation of an ISO 13485 QMS, CAPA processes and auditing. Key Responsibilities: Develop and Maintain ISO 13485 QMS Support the implementation and transition to an … scientific or technical field Proven experience in the IVD or Medical Device Industries Proven experience in the maintenance and/or implementation of an ISO 13485 QMS Proven experience and knowledge of CAPA Process and Auditing Auditing certification is highly advantageous If you have the necessary skills and more »

least one of: electronic devices, embedded software, or application software Proven years direct project management experience Proven record of successful project management within an ISO13485 or similar quality system Proven ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can more »

performance and accuracy of medical technologies.Algorithm Development- Develop prototype algorithmic functions based on data analysis and experimental findings.Quality Assurance: Assist in maintaining adherence to ISO 13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree 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 »

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 »

the continued performance, safety and reliability of our products. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed 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 »

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 »

intent and operational workflow of designed electronic systems to product engineering staff. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. From an educational perspective, you will be degree qualified in electronic engineering or a related field. Life at … analysis using modelling (Cadence and Xilinx) and experimental/prototyping methods Experience in DFx (design for manufacturing, assembly and test) Knowledge and appreciation of ISO13485 and FDA Medical Device Design Control Mentoring/leadership experience or strong potential/natural next step What next? We believe the key to unlocking more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

to tight deadlines and be able to manage your own time well. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. Life at Optos is fast-paced and everyone tends to chip in. We have an experienced team who more »

Supporting in house and contract engineers in Mechanical Engineering Creation and management of product and production Technical Documentation Manage and maintain engineering data within ISO 13485 QMS Engineering management of operations – Design Change, Compliance, Validation etc. Take ownership of engineering drawings and technical documentation relating to technical files 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 »

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 »

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 »

with design control standards. Background in the medical device sector to understand regulatory requirements and quality management systems (QMS) essential for successful product development. (ISO13485) Knowledge in mechanical engineering with a focus on testing equipment and innovation in product development. Requirements: Bachelor's degree in Electronics or Mechanical Engineering. Up more »

and attention to detail Working knowledge of ISO9000/IATF16949 – a plus would be experience in a strong compliance industry such as AS9100 or ISO13485 Internal Auditor qualified or lead auditor preferred against ISO9000/IATF16949 Past experience in a similar role is key Previous experience in the semiconductor industry 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 »

ll also develop prototype algorithmic functions based on data analysis and experimental findings. Additionally, you'll play a role in maintaining adherence to the ISO 13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal – Better patient more »

Engineering) or equivalent (e.g Pharma, Biopharm, Life Science, Biotech) Good Experience in Quality Assurance; Problem Solving, Analytical and Continual Improvements. Certified Lead Auditor in ISO 9001:2015 or 13485:2015 Proven background leading and managing teams working with minimum supervision under pressure to tight deadlines with customer focus. 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 »

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 »