1 to 25 of 63 ISO 13485 Jobs in the UK excluding London

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 »

you also have experience managing a small team of Quality Engineers, please read on! Main tasks and area of expertise: Maintaining the MDSAP and ISO 13485-certified Quality Management System. Ensure all procedures are up to date with changing standards and regulations and are being implemented by all … employees. Supporting the management of the Information Security Management System alongside the Information Security Officer (as per ISO 27001). Facilitate management reviews, notified body audits, supplier audits, and internal audits. Essential Prior experience of working for a small to medium-sized medical device company in quality or compliance … medical device regulations). External and internal audit experience, including hosting notified body audits, and conducting supplier quality assessments. Knowledge of quality standards including ISO 13485 and ISO 14971 Advantageous Qualification in regulatory affairs or quality assurance Knowledge of MDSAP regulations If this sound like a 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 »

Quality related regulations and standards Essential: ISO 9001, ISO 13485, GCP, Desirable: ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor (external audits more »

regulatory processes are followed meticulously. Report any QC pass and fails, monitoring any non-conformance closely and taking corrective action. Strictly adhere to all ISO 13485/FDA regulations. Follow SOP’s, maintaining accurate records and document all production activities in accordance with company policy. Your background: BSc … or equivalent in a Biological discipline (or related). Background in an IVD development setting, working to ISO 13485 standards in a production or QC team. Proven industry/commercial lab experience, ideally where there are devices in development. Good proficiency with RT-PCR along with other classic more »

to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »

Experience/Qualifications : Experience within the medical device industry, with knowledge of MDD 93/42/EEC, EU MDR (2017/745) and ISO 13485 is desirable Experience working with technical documentation and data management Experience working on multiple projects simultaneously Key Skills: Excellent technical reading comprehension … Assurance, Quality Assurance Coordinator, QA Coordinator, Health and Safety Officer, Audit, Medical Compliance, MDD 93/42/EEC, EU MDR (2017/745) ISO 13485 etc REF more »

including creating and implementing test plans. Maintain an appropriate working knowledge of medical standards including but not limited to IEC 60601-1 Ed 3; ISO 14971; IEC 62366; ISO 62304; ISO 13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of 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 »

engineering or science to degree level (preferred) Experience in a quality related role. Ability to inspect and measure produced parts (with experience) Experience of ISO 13485 or ISO 9001 Internal auditor qualification (preferred) Medical device manufacturing experience. Ability to communicate and liaise with different departments to ensure more »

work for a rapidly expanding medical device company. Our client is ideally looking for an experienced microbiologist who holds IVD related experience within an ISO 13485 or ISO 17025 setting. The Role Use specialised technical knowledge and skills to implement company research strategies to lead the development … mentoring junior staff members. Understanding of IVD medical device regulations. Experience working in a clinical microbiology laboratory would be ideal. Previous experience working to ISO 13485. Important Information: We endeavour to process your personal data in a fair and transparent manner. In applying for this role, Russell Taylor will more »

medical equipment work or internal project work. - Produce and update procedures that are relevant to their own area of expertise to maintain the RTS ISO 9001:2015 quality management system. - Teach and train members of staff in own area of expertise. - Carry out and organise internal resource management including … fault finding, preventative maintenance & calibration principles for complex equipment. - Advanced interpretation and creation of technical documentation. Medical Equipment Management: - Advanced understanding of RTS procedures, ISO standards, and Medical Device Regulations. - Participate in on-call system for equipment management services outside of normal working hours. Clinical & Scientific Support: - Provide technical … of knowledge. Professionally registered Clinical Technologist, Clinical Scientist or HCS Practitioner Desirable Formal leadership or management training Specialist medical technical training courses Accredited UKAS ISO 9001 and UKAS ISO 13485 training courses Skills & Behaviours Essential Evidence of fault analysis, diagnosis & repair skills for complex equipment including linear more »

Minimum of 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 (RTOS) and bare-metal 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 »

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 »

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 »

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 »

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 »

Qualifications: Experience the life sciences or similarly regulated industry (In-vitro Diagnostics preferred) A practical understanding of record audit and material approval processes per ISO 13485:2106 for the Design and Manufacture of In-vitro Diagnostics Experience with an Enterprise Resource Planning System (ERP) Experience with Electronic Document more »

the continued performance, safety and reliability of our products. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »