13 Permanent ISO 13485 Jobs in England with Remote Work Options

You’ll be responsible for supporting the compliance team to ensure all required certification is maintained. Complete internal audits in compliance with relevant standards (ISO 13485, 21 CFR, MDD/MDR and UKCA regulations) Assist in the logging, investigating, and documenting of all non-conformities Corrective and Preventative … someone with the following skills and experience; Ample experience in Quality Assurance specifically within medical devices Good knowledge of MDR is desired Knowledge of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable Experience of Internal Audit, ideally as a lead auditor (desired) Experience 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 »

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 »

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 »

particularly for development activities (change control, version management, documentation, testing, deployment, issue tracking etc.) Assisting with implementation of our quality systems and under the ISO 9001 framework Qualifications, Skills and Abilities Essential Experience in Embedded C Experience in Linux development for embedded systems Familiar with use of real-time … release management. Desirable Experience with digital electronics Experience with REST, JSON, protobuf Some experience with IoT technologies Developing firmware for medical devices Knowledge of ISO 13485 or IEC 62304 Closing Date: Sunday 26th May, 2024 IT-IS is committed to encouraging equality, diversity and inclusion among our workforce. 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 ISO 13485 or IEC 62304. Experience building medical applications, or applications in domains with similar regulatory constraints. Who you are: Consistently delivers high-quality more »

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 ISO 13485 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 »

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 »

vast quantities of raw data Experience with Python, including libraries such as NumPy, SciPy, Pandas etc. Any Medical Device Software experience and understanding of ISO 13485 would really set your application apart! What Next? If you’re a Data Analyst/Data Scientist looking to work on a 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 »

scalable, allowing personalised therapies to be affordable for more people. To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of … all stakeholders. Requirements: Graduated with a bachelor's or master's in engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with "quality management … offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus. Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs/Herts Border Another top job from ECM, the high-tech recruitment experts. Even if more »