1 to 25 of 30 Permanent ISO 13485 Jobs in the UK

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 ISO 13485 would be an advantage, good knowledge of Microsoft Office, Excel, Power Point Good communication skills to 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 ISO 13485 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 ISO 13485 would be an advantage. Eligibility to become GDP Responsible Person and Responsible Person for Import. Good more »

ideally have the following attributes: Degree qualified or experience working in similar role 2-4 years experience working with highly regulated standards. IATF 16949, ISO13485 or AS9100 Structured approach to problem solving methodologies APQP/PPAP experience Certified Lead auditor Electronic assembly experience beneficial Self-motivated individual, able to set 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 ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

usability engineering processes (with IEC 62366-1/FDA guidelines) to ensure safety and efficacy of medical devices for end-users Ensure adherence to ISO 13485 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 »

to reduce or mitigate any identified risks. Maintain knowledge of site policies and procedures, especially the quality system Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements. Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative … NC, CAPAs, Change Controls, Document updates, Risk Assessments. Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status. Perform local area and local system audits. Training/coaching of operations … a medical device or pharmaceutical quality function Qualified Internal Auditor Desirable: Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001 Ability to work in matrix teams. Experience of working with multiple QMS systems Understanding of the requirements of GDPR & ISO27001 Basic knowledge of the 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 ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements. Person Specification With previous experience as a Quality Engineer in manufacturing within a 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 ISO 13485, FDA Design Control and 510k submissions would be beneficial Desirable Experience/Qualifications: Knowledge/understanding of plastic injection moulding Experience of 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 »

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 »

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 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 »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive 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 »

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 »

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 »

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, ISO 13485 and GDP requirements. Job responsibilities of a Quality Assurance Operative include: Record and distribute meeting minutes Ensure calibration records more »

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 ISO 13485 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 »

CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO 13485, ISO 14708, and other relevant medical device standards. What Sets This Role Apart: Collaborate with top minds in an innovative, ethical 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 »

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 »

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, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II. On this occasion, LiCa Scientific is acting as an employment 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 »