1 to 25 of 69 ISO 13485 Jobs in the UK

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

Minimum of 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 (RTOS) and bare-metal 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 »

resourceful process driven graduate with an interest in quality assurance, who can research, recommend and assist with implementation of appropriate processes for ISO9001 and ISO13485 QA systems. The ideal candidate is an organized and methodical emerging professional who has the skills, confidence and abilities necessary to analyse requirements, sift hard more »

hire a Quality Engineer to join their team ASAP. Quality Engineer Role Overview : Responsibility for ensuring the implementation of process and their compliance to ISO 13485. Develop, implement and maintain quality assurance processes and support the Manufacturing Quality Team Lead on the promotion and awareness of Quality; Support the 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 »

of design and development documentation across various platforms. In this role, you'll offer documentation support for both new and existing projects within the ISO 9001 and ISO 13485 Quality Management Systems. We're looking for someone with a demonstrated track record in maintaining documentation within quality … technical documentation role, with expertise in administering technical/quality documentation that may be subject to audit or inspection by external bodies. Familiarity with ISO standards (particularly ISO 13485/9001) and other quality management systems (e.g., 27001) is highly desirable. Additionally, strong writing skills, teamwork abilities 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 »

We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission … biomedical sciences) * Two or more years of experience in regulatory affairs within the diagnostics or medical devices industry * Strong knowledge of FDA, EU regulations, ISO 13485, and ISO 14971 * Excellent communication and writing skills * Strong team-working, analytical, and problem-solving skills * Ability to make decisions and more »

Looking For: * Minimum 3 years of experience in regulatory affairs within the diagnostics industry. * Strong knowledge of IVD device regulations, including 21CFR, IVDR, and ISO 13485. * Excellent communication, writing, and problem-solving skills. * Ability to work effectively in multidisciplinary teams and make informed decisions. * Understanding of when to escalate 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 »

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 »

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 »

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 »

devices. Microsoft Azure certifications . Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »

the Head of Quality: Strong leadership and mentoring skills. Experience in Electronic Engineering Environment. Demonstrable knowledge and experience in an Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement more »

5+ years’ industry experience. Desirable: Previously involved in the development of wellness and/or medical devices. Experience coding to MISRA standards. Experience writing ISO 62304-compliant software (class A) under an ISO 13485 quality management system. Good understanding of wireless protocols, particularly Wi-Fi and Bluetooth. more »

professional and personal growth, all while valuing your unique contributions. Apply now for the position Quality Systems Engineer and you will ensure compliance with ISO13485, FDA 21 CFR Part 820 and other international regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post more »

robotics are used wherever possible, designing and implementing 6-axis cells and introduction electronic and logic controls to automate where possible. Comply with all ISO 13485 requirements. Knowledge, Skills & Experience: An experienced Injection Moulding Technician, with experience of manufacturing products to tight tolerances, using high grade polymers. Demonstrable more »

primed for you as an individual who is well versed in Quality Engineering within the medical technology sector. Areas such as MDR, MDD and ISO 13485 will be second nature to you as this opportunity will allow you to be the subject matter expert for the business, to … week from home. What will you be doing as their next appointed Quality Systems Engineer? Perform internal quality audits in line with their accreditation (ISO 13485) against work instructions, manufacturing proceedures etc. Maintain and support their Improvement Culture, using your insight and analysis from performing audits as to … with other internal stakeholders on QMS related activities. Ready to apply? This is what you will need to demonstrate; Qualified/Certified Auditor for ISO 13485 (please note, this is a deal breaker for our client) Hands on knowledge of IS0 3485 i.e. you have worked in medical more »

Working knowledge and experience with a Quality Management System, such as deviations, investigations, CAPA, and customer complaints. · (Desirable) Experience of ISO certified QMS (ISO13485) Knowledge (Essential) In depth understanding of approaches to quality for legal manufactures · (Desirable) Knowledge of quality regulations (such as, ISO 13485, ISO more »

of on-site and remote desktop audits. We’re interested in speaking to Lead Auditors with a background in any of the following fields: ISO 13485:2016 ISO 9001:2015 EU MDR ISO 17025:2017 for Calibration and Laboratory ISO 27001:2022 PCBA (printed circuit more »

Basic software development skills Electrical analogue and digital measurements Experience with Xilinx MPsoC is a plus Experience with FPGAs is a plus. Knowledge of ISO 13485, MDD/IVDD, IEC 60601x, ISO 14971 is a plus Knowledge of Risk Management processes (DFMEA, PFMEA, AFMEA), DHF, and Tech more »

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 »

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 »