1 to 25 of 25 Permanent ISO 13485 Jobs in the UK excluding London

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 ISO 13485 standards, and in compliance with EU GDP guidelines. Ideal you will have experience of working in a GMDP … Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Ensuring ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. Participating … attendance and presentation at meetings and the management of the meeting outputs. Promoting a positive quality culture within the organisation. Hosting and supporting Regulatory, ISO and Client audits and conducting Supplier audits, internal audits, and self-inspections, including the preparation of responses and CAPA plans. Key Skills/Experience more »

The ideal candidate will have significant experience as a Responsible Person working in a Good Distribution Practice (GDP) environment with a strong background in ISO 9001 and ideally ISO 13485 standards. Key Responsibilities: Developing, implementing, and maintaining robust quality assurance policies and procedures. Planning and conducting regular … support to staff on quality assurance standards and practices. Evaluating and managing suppliers and vendors to ensure they meet quality standards. Ensuring compliance with ISO 9001 and ISO 13485 (ideally) standards and other relevant regulatory requirements. Investigating and resolving quality-related issues and complaints, implementing corrective and … contingency plans. Requirements: Proven experience in a quality assurance/responsible person role Strong background in Good Distribution Practice (GDP) environments. Excellent knowledge of ISO 9001 and ideally ISO 13485 standards. Exceptional analytical and problem-solving skills. Detail-oriented with excellent organizational and record-keeping abilities. Strong more »

in the management, implementation and use of computerised healthcare technology including an understanding of DICOM and HL7 communication protocols. Knowledge of relevant standards including ISO 13485; ISO 14971; ISO9001; ISO 27001; IEC 80001; DCB0129; DCB0160. Knowledge and experience of using formal research methods. Desirable Experience in more »

of the software's behaviour and performance. Adherence to quality standards: Ensure that quality assurance adheres to quality standards and certifications such as the ISO 13485 to ensure we maintain compliance. Improve Quality Assurance: Strive to continuously enhance and automate all activities under the domain of QA to … environment is an integral part of the verification/validation process. Familiarity practising QA in adherence to quality standards and certifications (such as the ISO 13485). Experience integrating automation into CI/CD pipelines. Knowledge of version control systems such as 'Git'. Exposure to performance testing 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 »

Urgent position for a leading Medical Device company seeking a QA Software Engineer with 3+ years of SaMD experience with a strong knowledge of ISO 13485, ISO 60601 and IEC 62304 . The key responsibilities are as follows: • Ensure the software meets all relevant regulatory requirements • Alongside more »

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 »

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 »

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 »

solving skills, with the ability to work effectively with internal and external stakeholders. Familiarity with medical device regulations, standards, and best practices such as ISO 13485, IEC 62304, or FDA 21 CFR Part 11. Ability to work under pressure, meet deadlines, and deliver high-quality software products that 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 »

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 »

of test harness and tools using C#/.NET Use of circuit simulation packages Schematic capture and PCB design for small form-factor products. ISO 13485 or similar quality systems IEC 60601 family/IEC 62304 standards Previous work with medical devices Company Benefits Excellent salary Car Scheme 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 »

for improvement, contributing to continuous improvement initiatives. Qualifications, Skills and Abilities: HND/Graduate level or previous experience in Quality Assurance role Understanding of ISO13485 Previous experience work in In Vitro Devices or Medical Devices Attention to detail/concern for impact Good organisational and planning skills Good communication skills more »

Act as a business partner to the Group CIO and local teams, providing IT support and guidance. Ensure compliance with industry regulations such as ISO 13485, FDA, and MDR. Monitor and report on IT performance and budgets, identifying risks and opportunities. Stay informed on IT trends in the more »

their needs and expectations, and providing IT support and guidance. Ensure compliance with the regulations and standards of the medical devices market, such as ISO 13485, FDA, and MDR. Monitor and report on the IT performance and budget in the country, identifying risks and opportunities for improvement. Stay more »

process control tools, improvement techniques, and data analysis Familiarity with various joining and assembly techniques, lean manufacturing, and regulatory standards (e.g., FDA, MDR, EMA, ISO 13485) This is a fantastic opportunity to be at the heart of innovation in medical device manufacturing. You’ll work in a hybrid more »

close with the technical team to ensure proper design implementation and system integration. Ensuring the product design is carried on following relevant standards (i.e. ISO-13485, ISO-14971) and in compliance with company QMS. Actively contributing to the quality improvement process: Leading CAPAs, participating to the Change Management … within the medical device industry or other regulated industry. Experience implementing and applying MBSE. Familiarity with SysML. Experience with MDD/MDR. Experience applying ISO-13485 and ISO-14971. Familiarity with requirements and verification management tools such as DOORS or JAMA Drive for continuous improvement A naturally inquisitive more »

Senior Software Engineer Cardiff CF14 Commutable from Cardiff, Newport, Bridgend, Caerphilly, Barry, Llantrisant, Pontypridd Benefits:- Highly competitive salary Bonus Opportunity 25 Days + Bank Holidays Employee assistance programme Matched 5% pension Funded company social events Free on-site parking and more »

deliver risk analysis and technical leadership of products developed by Blatchford. Key duties. Ensuring the product design is carried on following relevant standards (i.e. ISO-13485, ISO-14971). Actively contributing to the quality improvement process: Leading CAPAs, participating to the Change Management activities, supporting the products roadmap … a set of subsystem requirements described by architectural diagrams and interface descriptions. Experience supporting systems engineering investigations. Experience with MDD/MDR. Experience applying ISO-13485 and ISO-14971. Naturally inquisitive problem solver Team player with a positive, “can do” attitude. Familiarity with requirements and verification management tools more »

cordless technology applications. Applying control engineering principles such as PD/PID controllers for system regulation. Engaging in coding and software lifecycle management per ISO13485, IEC6001, IEC62304, and other relevant standards. Collaborating with cross-functional teams to ensure effective product development and integration. Conducting feasibility reviews and troubleshooting to optimize … budget monitoring, and ensuring timely delivery of project milestones. The experience you'll bring to the team: Essential experience and knowledge in medical devices - ISO13485, IEC6001, IEC62304, cybersecurity Proficiency in coding with C and C++ Experience with microcontroller programming, e.g. STM32 Background in control engineering, specifically with PD/PID more »

requirements. Qualifications and experience Essential: Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline At least 3 years’ experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities (e.g. FDA, Notified Body, UK Approved Bodies). Excellent attention to detail … organisational, team-working and communication skills. Experience managing a quality system, ISO compliance and internal and external audits. Proactive thinking, designing and implementing processes from scratch and working collaboratively in a small, fast-paced and interdisciplinary team. Motivation to learn and continuous improvement mindset. Preferred: Experience working with technical … with quality for Software as a Medical Device products and/or connected devices Experience supporting a Quality Management Rep Hands-on experience with ISO13485 audits 52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to more »

also take on quality management responsibilities as Management Quality Representative, becoming responsible for all aspects of the QMS, including: Achieving and maintaining full-scope ISO13485 certification Approving QMS records Delivering on quality objectives Ensuring quality training is up to date for all staff and that staff understand and follow QMS … marking/FDA approval for a new-to-market Class II/III/Class C/D IVD. Experience managing a quality system, ISO compliance and internal and external audits. Excellent organisational, team-working and communication skills. Proven track record of delivering projects, proactive thinking, designing and implementing … and/or connected devices Experience gaining regulatory approval for a self-test Experience as a Quality Management Rep or PRRC Experience with gaining ISO13485 certification from scratch Experience working in a Notified Body or equivalent 52North is an equal opportunity employer and is committed to providing equal employment opportunities more »

handover. You will also interface with project managers, and other supporting functions to achieve company goals. Key duties. Contributing to Risk Analysis (compliant with ISO-14971), definition of requirements and related test cases for products. Contributing to design reviews, assessments of change requests and CAPAs implementation. Contributing to the … to maintenance and decommissioning. Owning assigned activities from definition to full completion within the planned schedule, in line with internal procedures and standards (e.g. ISO-13485). What are we looking for? To be considered for the System Engineer opportunity, you will have the following: Essential skills MSc in … understanding across other engineering domains, i.e. electrical, mechanical, software. Excellent knowledge of MBSE and other Systems Engineering principles, standards and best practices. Experience applying ISO-13485 and ISO-14971. Familiarity with requirements and verification management tools such as JAMA Experience of designing products requiring combined mechanical, electronic and more »