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 »
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 »
requirements, identify gaps, and apply boundary analysis and other formal techniques to requirements. Knowledge of medical device Quality Management Systems and standards such as ISO13485 or IEC 62304. Experience building medical applications, or applications in domains with similar regulatory constraints. Who you are: Consistently delivers high-quality 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 »
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 »
expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers more »
experience in software testing, preferably in the medical device industry. (or other safety-critical industries) • Familiarity with medical device regulations and standards such as ISO13485, IEC 62304, and 21 CFR 820 • Proficiency in testing tools and frameworks such as Selenium, TestNG, Cucumber, TestArchitect, etc. • Certification in software 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 »
vast quantities of raw data Experience with Python, including libraries such as NumPy, SciPy, Pandas etc. Any Medical Device Software experience and understanding of ISO13485 would really set your application apart! What Next? If you’re a Data Analyst/Data Scientist looking to work on a more »
