26 to 50 of 53 ISO 13485 Jobs in the UK excluding London

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 »

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 »

activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering 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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

products and design new ones Lead presentations and liaise with senior management on a daily basis Have a good understanding of IEC60601 family standards, ISO13485, ISO14971 and BSEN62304 This is a highly varied, challenging and interesting role with an employer of choice in Caerphilly. Not only will you benefit from more »

system Updating documentation as required Manage the filing of incoming and outgoing documents Collating and collecting relevant data Managing the archive system Experience in ISO 13485:2016 If you are interested in this position please apply today more »