1 to 17 of 17 ISO 13485 Jobs in the South East

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 »

identification. Conduct quality audits across all organisations. Performance Measures: Maintain documented quality systems across the group. Support internal and external audits for compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other regulations. Prepare and maintain QMS and … documentation. Assist QA Admin team with product approvals for UK and international markets. Evaluate suppliers and conduct approval audits. Document quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and non-conformance investigations. … Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and global device directives/regulations. Maintain technical/design history files for compliance. Medical experience in a production/manufacturing environment. Internal and external quality auditing experience 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 »

Experience/Qualifications : Experience within the medical device industry, with knowledge of MDD 93/42/EEC, EU MDR (2017/745) and ISO 13485 is desirable Experience working with technical documentation and data management Experience working on multiple projects simultaneously Key Skills: Excellent technical reading comprehension … Assurance, Quality Assurance Coordinator, QA Coordinator, Health and Safety Officer, Audit, Medical Compliance, MDD 93/42/EEC, EU MDR (2017/745) ISO 13485 etc REF 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 »

software for their advanced diagnostic systems, collaborating closely with internal and external software teams. Role requirements: Experience in regulated IVD development, including compliance with 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 »

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 »

organisation whilst assisting meeting our regulatory responsibilities. Key duties: Implementation, maintenance, continuous improvement, and support of Blatchford’s Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaboration across internal departments to provide Quality Assurance support. Participation in external Quality audit activities. Representing QA for … qualified or equivalent experience in similar role Internal audit qualification Demonstrated experience in a Quality Assurance role, which includes auditing. Good working knowledge of ISO 13485 (Desirable) Strong communicator with good interpersonal Highly analytical Able to assess information and data leading to rational judgements and successful conclusions. Ability 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 »

all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead 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 »

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 »

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 »

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 »

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 »