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, ISO13485, ISOmore »
improvement tools and methodologies (Six Sigma, Mistake Proofing, Kaizen, etc). The Head of Quality Assurance & Testing Experience & Skills: Demonstrable knowledge and experience in ISO 9000, ISO 9001, ISO13485, TS16949, ISO14001 previous Quality Management experience, plus having completed successful improvement projects. Experience dealing with £multi more »
Greater London, England, United Kingdom Hybrid / WFH Options
RedRock Consulting
based care. The concentration of the role is the production of software medical device technical documentation in compliance with the Medical Device Regulation and ISO13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards. Suitable candidates will have … Directive/Medical Device Regulation transition process. Up to-date working knowledge of the following: MDD and MDR (Class 1 & 11a devices); BS EN ISO13485, 14971, 14155, 2700; BS EN IEC 606; BS EN 62304; NHS DCB0129/DCB0160 Additionally, you will have the following: Good working more »
the Head of Quality: Strong leadership and mentoring skills. Recent experience with NPI and ISO14001 Experience in Electronic Engineering Environment. Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement 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 ISO13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal Better patient more »
South West London, London, United Kingdom Hybrid / WFH Options
Austin Vita
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 ISO13485 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 »
phasing, mapped reads, signal to noise, quality etc) Working to maintain an accurate and efficient Quality Management System, fulfilling all relevant documentation commensurate with ISO13485 quality standard Person specification: Masters or PhD in a relevant field such as Applied Mathematics, Biomedical Engineering, Chemistry, Physics, Bioinformatics, or related more »
South Croydon, London, United Kingdom Hybrid / WFH Options
Melbreck Technical Recruitment Ltd
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 »
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 »
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 ISO13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree more »