18 of 18 ISO 13485 Jobs in the South East

full software development lifecycle, including requirements definition, architecture, implementation, testing, risk, cybersecurity and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, ISO 14971 and other relevant safety standards. Establish and enforce high-quality software design control practices, including code reviews. … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

teams, product and project managers, researchers, and external regulatory specialists, the candidate will design and implement a QMS aligned with relevant international standards, including ISO 13485 and ISO/IEC 27001, while supporting the platform's longer-term regulatory strategy. The candidate will lead the development … experience implementing or maintaining Quality Management Systems within medical devices, digital health, life sciences or regulated software environments. 2. Familiarity with relevant standards, specifically ISO 9001. 3. Experience in managing change control processes and supporting regulatory certification preparations and documentation. 4. Excellent technical writing and documentation skills, with ...

Oversee the full software development lifecycle, including requirements definition, architecture, implementation, testing, and maintenance. Ensure compliance with applicable regulatory standards and frameworks, including FDA, ISO 13485, IEC 62304, and other relevant safety standards. Establish and enforce high-quality software engineering practices, including code reviews, architectural governance, and design … accelerate development and testing. Strong expertise in IoMT technologies and cloud-based system integration. Comprehensive knowledge of regulatory standards and frameworks, including IEC 62304, ISO 14971, FDA guidance, ISO 13485 and ISO 62366. Ability to tailor compliance approaches while maintaining focus on risk, cybersecurity, scalability, maintainability ...

/EMI, signal integrity and reliable electronic design, with technical documentation and communication skills. Understanding of regulated product development and standards such as ISO 13485, ISO 14971 and IEC 60601. ...

relevant machinery safety standards and company policies. Conduct risk assessments and implement safeguarding measures for automated equipment. Support compliance with quality management systems, including ISO 9001 and ISO 13485 where applicable. Maintain accurate engineering documentation, including electrical drawings, specifications, and validation records. Qualifications & Experience Essential Degree ...

part of the role Experience of line management, supervision or mentoring of technical, manufacturing or workshop-based staff Desirable Criteria Experience of quality auditing, ISO 9001, 13485, or similar, supplier management, line management or regulated manufacturing environments Experience of CAD, rapid prototyping, product development and collaboration with design ...

bring The essentials: Degree in Electronics Engineering, Electrical Engineering, or related discipline. Proven experience in electronics design for medical or regulated devices (ISO 13485 environment preferred). Proficiency in Altium Designer for schematic capture and multi‐layer PCB layout. Strong understanding of STM32 microprocessors, BLE, power/battery … Familiarity with DFM/DFT principles and working with contract manufacturers. Understanding of wireless regulatory testing (CE/FCC) and EMC design. Knowledge of ISO 14971 risk management and medical device development processes. Embedded systems development experience. Why Neupulse? Make a tangible difference. Your work on cutting‐edge wearable ...

considerations and design-for-manufacture principles. Experience with electronic testing tools such as oscilloscopes, spectrum analysers, and logic analysers. Understanding of medical device standards (ISO 13485, IEC 60601, IEC 62304) is an advantage. Ability to troubleshoot and solve complex design issues. Effective communication skills for working within cross ...

. Qualifications: Degree in Mechanical, Electrical, Mechatronics, or Automation Engineering (or equivalent hands-on experience). Pluses: Robotics integration (6-axis/SCARA), ISO 13485/GAMP knowledge, or Six Sigma training. ...

solving skills. Good IT skills, including Microsoft Office and MRP/ERP systems. Desirable 5+ years' mechanical inspection experience. Knowledge of FDA, GMP and ISO 13485 standards. Engineering qualification, apprenticeship, or equivalent industry experience. Experience working within regulated manufacturing environments. Key Skills CMM Programming & Inspection (Essential) LK & Mitutoyo ...

data using analytical and statistical methods. (desirable) Degree in STEM related subject. Early career experience within a regulated or technical environment (desirable) Exposure to ISO 13485 or laboratory quality systems. (desirable) Experience with mechanical testing or laboratory instrumentation. (desirable) Interest in medical devices and combination products.(desirable) What ...

also possess previous experience in: Experience in one or more: cell culture, media development, bio-processing, life science, as well as familiarity with ISO 13485 Proficient with project management principles (e.g., resource allocation, cost estimation, risks analysis) & project management tools and applications software to manage complex project timelines. ...

ability to assess and improve working practices within the Warehouse. Competence in Vitalograph procedures and the Quality Management System (QMS). An understanding of ISO 13485, the Medical Devices Directive and GCP, as required. If youre looking for a hands-on role where you can develop your technical ...

firmware. You will collaborate with an external partner today, then build an in‐house capability, ensuring traceability, regulatory compliance, and robust releases aligned with ISO 13485 and IEC 62304. Hybrid role in Basingstoke. #J-18808-Ljbffr ...

threat assessment, vulnerability management, and secure device updates Work shoulder to shoulder with hardware, software, quality and regulatory, keeping everything traceable and compliant with ISO 13485 and IEC 62304 You’ll likely bring 5+ years delivering embedded firmware through the full product lifecycle, with a track record ...

other cancers a plus) International experience (work or study abroad) esp in North America, Europe and APAC Experience working within regulated environments (e.g. ISO 13485) What we offer Work that is both challenging and rewarding and has a real positive impact on people's lives Fast growth, ownership ...

A great opportunity to work as a Quality Assurance Coordinator for our client who are a health and beauty manufacturer and producer. Staffline are recruiting for Quality Assurance Coordinator in Alton. The rate of pay ...

/Clinical industry. Strong project and resource management skills with ability to manage multiple projects. Experience working with Quality Framework (ISO) standards (e.g.ISO27001, ISO13485) and ICH GCP, and understanding of 21 CFR Part 11 regulation. Proactive, analytical, and problemsolving skills with commitment for continuous improvement. #J-18808-Ljbffr ...