66 ISO 13485 Jobs in England

digital health apps deployed on mobile devices. 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 »

concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and more »

Supporting in house and contract engineers in Mechanical Engineering Creation and management of product and production Technical Documentation Manage and maintain engineering data within ISO 13485 QMS Engineering management of operations – Design Change, Compliance, Validation etc. Take ownership of engineering drawings and technical documentation relating to technical files more »

a relevant scientific discipline. Significant (>3 years) relevant technical experience. Nucleic acid assay development experience. Commercial IVD product development experience. Quality Management & Regulatory frameworks, ISO 13485, FDA 21 CFR 820 and cGMP. Previous line management experience. Strong laboratory-based background. Attention to detail and well organized. Please share more »

Engineer, Berkshire: - Experienced in mechanical and electrical testing - Experience in both hands-on testing and documentation writing - Experience in highly regulated industries - Experience of ISO13485 is highly desirable For more information or to apply for the Contract Verification Engineer opportunity based in Berkshire, please contact Jack Kelly -/ more »

and mechanical systems. Provide guidance to help develop and implement system improvements. Experience in writing, editing, or addressing product requirements. Previous experience working with ISO13485 beneficial. Sound like you or someone you know? If so, please do not hesitate to get in contact with Darren Holmes at Vector Recruitment Ltd more »

Engineering) or equivalent (e.g Pharma, Biopharm, Life Science, Biotech) Good Experience in Quality Assurance; Problem Solving, Analytical and Continual Improvements. Certified Lead Auditor in ISO 9001:2015 or 13485:2015 Proven background leading and managing teams working with minimum supervision under pressure to tight deadlines with customer focus. more »

scalable, allowing personalised therapies to be affordable for more people. To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of … all stakeholders. Requirements: Graduated with a bachelor's or master's in engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with "quality management … offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus. Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs/Herts Border Another top job from ECM, the high-tech recruitment experts. Even if more »

refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW more »

the business maintains and improves regulatory readiness through organic growth and future acquisitions.Be accountable and provide SME Quality advice whilst the business transitions into ISO13485 accreditation.Build and maintain strong relationships with the rest of the SLT and key stakeholders.Continuous improvement and updating of the Quality Management System Framework and Strategies … managerial responsibilities.Ideally knowledge/experience of complex products within instrumentation including software components/elements.Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards.Ability to collaborate and influence across multi-functional teams and stakeholders.Excellent verbal and written communication skills, and experience with technical writing including authoring and revising more »

similar. Experience in process and product validation (sterile packaging according to ISO 11607 would be advantageous). Understanding of a quality management system (ISO13485/FDA) and medical device manufacturing advantageous. Very good MS-Office skills, especially Excel. Strong organizational skills with the ability to communicate at all levels more »

laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »

on-Severn, Kidderminster, Great Malvern Are you a Quality Engineer from a manufacturing/medical background with extensive knowledge of ISO9001 or understanding of ISO13485 looking for your next step into a varied role with a market-leading company, where you will be the go to Quality expert that will … report correctly on all things Quality. This role would suit a Quality Engineer from a manufacturing or medical background with knowledge of ISO9001 or ISO13485 looking for an autonomous and technically challenging role within a well-established company offering support to further qualifications and opportunities for ongoing technical progression. THE … product auditing and product testing * Root cause analysis * Report correctly and support purchasing team THE PERSON: * Quality Engineer or similar * Knowledge of ISO9001 or ISO13485 * Quality qualifications * Manufacturing or Medical background * Commutable to Worcester Reference Number: BBBH13431 Key Words: QA, Quality, Assurance, Manager, Engineering, Medical, Implants, ISO9001, ISO13485, Worcester, Droitwich more »

Would you like to be part of a team helping to create something truly ground-breaking and game changing in the medical device industry? We have a world class diagnostic technology that enables rapid detection of respiratory viruses such as more »

Job DescriptionWould you like to be part of a team helping to create something truly ground-breaking and game changing in the medical device industry? We have a world class diagnostic technology that enables rapid detection of respiratory viruses such more »