1 to 25 of 39 ISO 13485 Jobs

To maintain awareness of existing and new legislation/guidance relating to EU and UK GXP for medicinal products and medical devices including all ISO activities relevant to medical devices including ISO 9001, ISO 13485 and ISO 14971; Controlled Drugs; Nutritional Products; and General Data … Protection Regulations and the UK Data Protection Act. What will you be doing? Maintaining Aspire Pharma Limiteds EU and UK GXP/ISO 9001/ISO 13485/ISO 14971 QMS, including: Staff training. Documentation control. Change control. Non-conformance/deviations. Validation. Corrective and/ 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 »

ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO 13485 ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we more »

support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … to urgently and accurately perform all operations required during a pharmaceutical recall. Key Skills/Experience/Requirements: Good knowledge of GDP and the ISO 9001 standard, understanding of ISO 13485 would be an advantage. Eligibility to become GDP Responsible Person and Responsible Person for Import. Good 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 »

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 »

times. The successful candidate will be responsible for supporting product conformity and continuous improvement activities within the quality department. You will be working to ISO 13485 standards, with training available in this area if required. If you are a Quality Engineer looking for a role offering variety and … is the role for you. For further details, please click apply and contact - THADDEE - REF 3625 - 0117 966 1115. The Role: * Quality Engineer ensuring ISO 13485 standards * Internal and external training provided within a specialist field * Monday to Friday, 9:00am - 5:00pm The Candidate: * Working experience as … a Quality Engineer * Experience ensuring ISO 9001 standards are met * Commutable to Worcester Revorec Recruitment Solutions is a specialist recruiter for Engineering, IT and Science roles ranging from mid to senior level positions. Please be aware that we will only accept applications from candidates that have a valid work more »

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 »

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 »

Operative you willbe responsible for the day to day quality administrative tasks and supporting the department to ensure that the business is compliant to ISO 9001, ISO 13485 and GDP requirements. Job responsibilities of a Quality Assurance Operative include: Record and distribute meeting minutes Ensure calibration records 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 »

the Head of QA and responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 standards, and in compliance with EU GDP guidelines. In addition to this you will initiate and attend regular QualitySystem Management Review meetings, and … Key Skills/Experience/Requirements: Successful candidate MUST be eligible to become a Responsible Person for Import. Exceptional knowledge of GDP and the ISO 9001 standard, understanding of ISO 13485 would be an advantage, good knowledge of Microsoft Office, Excel, Power Point Good communication skills to 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 »

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 »

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 »

previous experience within a senior buying role is required. Experience of working according to industry standards e.g., quality management systems such as ISO9001 or ISO13485 is essential. Working knowledge of appropriate regulations and good practices. Experience in regulated environment is an advantage (e.g. medical devices, pharma, aerospace) Person Specification Expertise more »

production process and creating quality checkpoints. Review batch records, ensuring error-free manufacturing and batch release, including improving batch record templates. Maintain compliance with ISO13485 and CFR Part 820 Support the implementation and ongoing management of an eQMS. Essential Skills & Experience Relevant engineering or science degree and/or relevant … etc. Desirable Skills & Experience Previous experience of working with electronic components Experience in Quality Control function such as inspection and measurement. An understanding of ISO 13485:2016 MDR, UKCA, and 21 CFR Part 820 requirements. Person Specification With previous experience as a Quality Engineer in manufacturing within a 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 »

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 »

usability engineering processes (with IEC 62366-1/FDA guidelines) to ensure safety and efficacy of medical devices for end-users Ensure adherence to ISO 13485 standards (training will be provided) Complete the testing section of technical files prior to product launch Articulate comprehensive justifications for determining sample … assurance preferred Experience leading a small team would be advantageous Knowledge of industry standards and regulations related to V&V processes preferred, such as ISO standards, FDA regulations (for medical devices) Valuable Expertise: Leadership skills to coordinate a small team Detail orientated and analytical thinker to quickly detect issues more »

Experience working with early-stage products. Experience developing approval ready devices and products. Experience with C++ & C also useful. Experience within Medical Devices Sector (ISO 13485). If interested, please apply, or reach out for further information about the role more »

Experience of both quality management systems and complete engineering lifecycles and processes, along with an understanding of Medical Device Regulation (MDR) requirements, together with ISO 13485, FDA Design Control and 510k submissions would be beneficial Desirable Experience/Qualifications: Knowledge/understanding of plastic injection moulding Experience of more »

is compulsory Knowledge of design control, risk management, root cause investigation methods, process validation, statistical process control (SPC), protocol/report preparation. Knowledge of ISO 13485, European Medical Device Regulation and FDA 21 CFR 820 requirements, understanding the medical device regulatory environment and requirements Familiar with QMS processes 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 »