26 to 50 of 60 ISO 13485 Jobs in England

CAP, ISO15189 laboratory requirements Experience in CLSI, NYDOH and other industry standards for assay validation; Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations. Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have 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 »

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 »

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 »

and H&S management systems and their application to high technology & engineering environments Comprehensive understanding of the requirements and application of ISO9001 quality standard, ISO 13485 quality systems for medical devices standard ISO45001 Occupational Health & Safety management standard and ISO14000 environmental management standard Qualified auditor Enthusiastic, inquisitive & self 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 »

team in performing environmental monitoring in line with the requirements of Standard Operating Procedures (SOP's). Follow all requirements of working in an ISO 13485/FDA regulated environment. The Senior Quality Control Scientist will have the following skills and experience: Batchelors degree in Molecular … biology or similar (or equivalent experience). Recent and relevant in Quality Control for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment. Hands on experience of PCR and understanding of underlying principles. Familiarity with operating under formal quality systems and practices, such as … ISO13485 and FDA regulations. Practical experience within the Life Science industry would be a distinct advantage. Interested or know someone who might be? If so, get in contact with Darren Holmes @ Vector Recruitment Ltd on 01234 815474 or more »

phasing, mapped reads, signal to noise, quality etc) Working to maintain an accurate and efficient Quality Management System, fulfilling all relevant documentation commensurate with ISO 13485 quality standard Person specification: Masters or PhD in a relevant field such as Applied Mathematics, Biomedical Engineering, Chemistry, Physics, Bioinformatics, or related 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 »

are: A background in electronics and/or electro-mechanical assemblies is essential for this role, and experience with Quality management systems such as ISO13485, AS9100 or ISO9001 Electro-mechanical apprenticeship or similar higher education award in this or an associated area e.G., HNC, HND or Level 3 NVQ in more »

. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »

Experience operating in ISO9001 environment Excellent working knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory … Specialist, Quality Assurance Manager, QA Manager, ISO9001, ISO 13485 Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency 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 »

functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO 13485, and IATF 16949, is a plus Experience working with suppliers and customers more »

To ensure that the project information is well maintained; for example, budget costs, folders, linked projects To ensure compliance to FDA/NPMA/ISO 13485, as well as supporting Medical Device Directive/Regulations documentation Desirable Experience/Qualifications: Degree within project management or a related field more »

when required ROLE REQUIREMENTS · 5 years minimum of relevant medical and healthcare product design experience · Degree in Design or Engineering related discipline · Familiarity with ISO 13485 working processes · Motivation towards the application of human factors to product development · Excellent 3D CAD skills (preferably SolidWorks) ABOUT US At Oxford more »

of existing QMS documentation (SOP’s, WI’s policies) Contribution to the development of new QMS procedure Essential Experience: A familiarity with operating to ISO13485 and compliant processes & procedures QA and preferably QC experience in a medical device company Degree qualified or quality qualification Minimum 2 years’ experience in a more »

FAIRS. Quality Manager - Part time/Maternity Cover Position Requirements Proven experience with a Quality Management role ISO9001 internal auditing experience A knowledge of ISO13485 standards is desirable but not essential Experience with QMS and ERP systems Based in a commutable distance of Forest Row Quality Manager - Part time/ more »

Support engineers and contract engineers in mechanical engineering. Create and m anage product and production technical documentation. Maintain the companys engineering data , within a ISO13485 QMS. Have responsibility for engineering drawings (BS 8888) and technical documentation , reports relating to technical files for medical devices. Work collaboratively with contracted design agencies more »

Desirable requirements Knowledge of medical device regulations such as 21 CFR 820 (QSR) or the 2017/745 MDR and international standards such as ISO 13485 or other regulated industries. Knowledge of Agile Project Management and/or Scrum Methodology. Both Mechanical and Software Development Projects more »

deployed on mobile devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

controlling other medical devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

deployed on mobile devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

managing or supporting the management of scientific or engineering projects. Ability to work to the Company’s Quality Systems and Policies in line with ISO13485 standards. Advanced experience with Microsoft Word and Excel. Great communication skills. Be eligible to work full time in the UK without restriction. Excellent work ethic more »