1 to 25 of 54 ISO 13485 Jobs in the UK excluding London

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 »

product claims. To support business units in the method design, development, and validation of new analytical test methods upon request. Duties Maintain compliance to ISO13485 and ISO9001 standards in accordance with GLP/GMP compliant procedures. Analysing, documenting, interpreting, and reporting laboratory data to GMP/GLP standards. Collation and more »

Software development toolchains – Azure Devops, Visual Studio Experience of design and validation of medical device software or other safety critical/regulated environments i.e. ISO 13485, EN 62304, 21 CFR 820, ISO 14971 compliance Curious and eager to learn with a growth mindset. This is a fantastic more »

would be a strong benefit to have knowledge of NGS and molecular testing methods An appreciation of the regulatory requirements for a clinical laboratory (ISO 15189) and/or IVD, ISO 13485 Good written and verbal communication skills, and able to work effectively in a busy and more »

genomes. Reporting to the Vice President of Quality & Operations the Quality Engineer will have a central role in the continued implementation & improvement of the ISO 9001 Quality Management System. You will work across functions to help integrate the new QMS into our everyday processes. You will have the opportunity … quality function & culture, within a rapidly expanding company & market. Responsibilities: Collaborate with teams across the company to continue the implementation, maintenance, & improvement of the ISO 9001 Quality Management System. Ensure that the processes needed for the quality management system are operated in such a way that a culture of … assurance activities. Administering the audit programme to ensure that it is operating effectively & to the approved schedule. Skills & Experience: 2+ years’ experience working under ISO standard QMS (9001, 13485, 15189, 17025). Experience of document lifecycle management & in nonconformance & CAPA systems Experience of working within electronic Quality Management 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 »

thinking A solid understanding of technical information/interpretation of 2D drawings Accuracy with data entry Familiar working within quality systems (eg ISO9001 or ISO13485) and with RoHS, WEEE. more »

and regular tracking of issues related to material non-conformance Ideal candidates will have the following attributes; Internal or Lead Auditor to AS9100 or ISO13485 Confident in generating/remodelling/facilitating business processes Performing audits that include; supplier audits, and process compliance audits Detailed understanding of root cause analysis more »

As pioneers in deploying medical devices and digital products to the healthcare market, we abide by a comprehensive quality management system in compliance with ISO 13485. While familiarity with the relevant market policies, processes, and requirements would be a bonus, we're ready to provide the training and support 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 »

NeuroTech AIMDs. Understands the end-to-end process for Class III Medical Devices. Has worked with contract manufacturers or built an internal manufacturing capability. ISO understanding across ISO 13485 requirements. How do I apply? To apply for this outstanding opportunity, please contact Nathan Sasso at Pivotal via 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 »

engineering or science to degree level (preferred) Experience in a quality related role. Ability to inspect and measure produced parts (with experience) Experience of ISO 13485 or ISO 9001 Internal auditor qualification (preferred) Medical device manufacturing experience. Ability to communicate and liaise with different departments to ensure 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »