21 ISO 13485 Jobs in the South East

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 »

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 »

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 »

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 »

and developing a positive Quality culture within the organisation. Supporting all other departments to ensure they remain compliant to the accreditations. Primarily, the AS9100, ISO 9001, ISO 13485 (Medical Devices) accreditations for the Company and such other schemes or programs which arise through Customer or market needs … equivalent. Experience (minimum 2 years) in a quality position within a manufacturing/engineering environment. Experience working within one of the following regulated industries: ISO 9001, AS 9100, ISO 13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in 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 »

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 »

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 »

of diagnostic technology! Due to the imminent global release of this product, you will need to adhere to the requirements of medical device regulations – ISO 13485/FDA environments. As the Senior Verification & Validation Engineer, your responsibilities will include: Lead the planning of verification activities for the system … Instrument and test consumable. Ensure tests are designed in alignment with product requirements will full traceability. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the … degree or equivalent hands-on experience. Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Experience in writing, editing, or addressing product requirements. Proficiency in both Mechanical and Electrical Engineering disciplines. Track record of submitting regulated 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 »

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 »

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 »

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 »

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 »

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 »

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 »

doing Creating and documenting software for their future product pipeline. Follow all relevant medical device standards in the creation and documentation of software (notably ISO13485, ISO62304 and ISO14971). Write efficient, logical, and well commented and documented code. Perform the verification and validation of the code, including module, sub-system more »

products Excellent communication and interpersonal skills for client and colleague relationship-building Experience in team management (preferably Agile methodologies) BONUS POINTS FOR: Familiarity with ISO 9001 and ISO 13485 standards for medical device projects Background or experience with a design consultancy engineering environment Breadth of skills is 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 »