26 to 39 of 39 ISO 13485 Jobs

CAD, and manufacturing design in a regulated setting. Comprehensive knowledge of regulatory standards, including FDA and CE marking for Class III devices. Familiarity with ISO 13485, ISO 14708, and other relevant medical device standards. What Sets This Role Apart: Collaborate with top minds in an innovative, ethical more »

development to launch and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »

processes including injection moulding, machining and fabrication Depth of knowledge of manufacturing processes (for plastic/metal) and its design requirements Strong knowledge of ISO13485 or other quality management systems Ideal but not compulsory: Medical device development experience Project management experience Understanding of electrical engineering integration Consultancy experience Please attach more »

developing automated testing and data collection. • Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) EDUCATION AND EXPERIENCE: What is the usual educational background and work experience of an individual qualified to perform this job? • B.S. degree in Electronics more »

candidates working in other areas of life sciences quality, such as Analytical Chemists, who seek a move into Quality Assurance! Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II. On this occasion, LiCa Scientific is acting as an employment more »

be able to do? Knowledge of the U.S. FDA Quality System Regulation, 21 CFR Part 820 (QSR), and knowledge of international quality system standards, ISO 13485, ISO 9001. Evaluate electronic component data sheets and characteristics and their applicability to specific circuit applications. Improve and create department processes more »

need to be able to do? Knowledge of medical device quality system regulations and standards (eg, U.S. FDA Quality System Regulation 21CFR Part 820, ISO13485, ISO9001) Knowledge of complete camera processing pipeline and image and video processing techniques, including image enhancement, auto exposure control, color correction, noise reduction, gamma correction … lbs.). Ability to connect electrical devices. TRAINING REQUIREMENTS: Safety, regulatory compliance, legal & job specific. Injury and Illness Prevention Program; annually - OSHA requirement ISO 9001/QSR/MDD, annually - In house requirement Blood borne Pathogen annually - OSHA requirement Job Specific - In house requirement Your Benefits Medical/Dental more »

At least 5 years' experience in developing software and troubleshooting hardware issues * Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304 * Significant experience in formal software verification * Proficiency in C/C++ programming languages * Experience with Real-Time Operating Systems and bare-metal development more »

and resolve issues. Perform formal software verification. Qualifications To succeed in this role, you should have: 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 »

include, process validation, defect analysis, corrective and preventive action, problem solving activities related to products and processes, performing internal audits to verify compliance with ISO and FDA Regulations, supporting external audits, and developing and implementing test and measurement techniques. Responsible for the supervision of technicians, as applicable. II. MINIMUM … the Company's Equal Employment and Affirmative Action Policies, including policies on the rights of individuals with disabilities and harassment. • Be knowledgeable in FDA, ISO, MDR regulations as applicable. • Lead company initiatives related to quality systems improvements/changes or technical improvements/changes. • Write/execute process validation … management personnel. • The incumbent in this position is responsible for knowledge of and adherence to environmental policies and company procedures as they relate to ISO 14001. • Must not pose a direct threat or significant risk of substantial harm to the safety of himself/herself or others. • Responsible for 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 »

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 »

quality assurance activities including root cause analysis and quality improvement. Main responsibilities: Maintain and enhance the Quality Management System (QMS) to ensure compliance with ISO 9001, AS9100, ISO 13485, and other relevant standards. Facilitate, control, and conduct internal audits to ensure continuous compliance and improvement. Assist in … with Root Cause Corrective Action investigations, 8D problem solving techniques and Failure Mode Effect Analysis (FMEA) processes. Experience in auditing and maintaining compliance with ISO standards such as ISO 9001 (AS9100, ISO 13485, IPC610 & IPC620 desired but not essential) Strong skills in customer interaction and managing more »

of continuous improvement. Provide training and support to staff on GDP compliance and quality assurance processes. Required Skills: Solid understanding of GDP regulations and ISO 9001 and ISO 13485 standards. Proven experience in a quality assurance role, preferably within the distribution, logistics, or pharmaceutical sector. Exceptional attention more »