Newcastle, Staffordshire, West Midlands, United Kingdom
The Electronics Group Ltd
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, ISO13485, 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, ISO13485, IPC610 & IPC620 desired but not essential) Strong skills in customer interaction and managing more »
Bristol, Avon, South West, United Kingdom Hybrid / WFH Options
Smartbox Assistive Technology
ensuring timely delivery, effective resource allocation, and successful project outcomes. Global Perspective. Useful Qualifications/skills/experience Experience in a medical device company ISO 9001 ISO13485ISO 60601-1 ISO 14971 EU MDR FDA Medical Devices Why join us? Here at Smartbox, we more »
and developing a positive Quality culture within the organisation. Supporting all other departments to ensure they remain compliant to the accreditations. Primarily, the AS9100, ISO 9001, ISO13485 (Medical Devices) accreditations for the Company and such other schemes or programs which arise through Customer or market needs … equivalent. Experience (minimum 2 years) in a quality position within a manufacturing/engineering environment. Experience working within one of the following regulated industries: ISO 9001, AS 9100, ISO13485, IATF 16949. Experience in problem solving and investigation tools such as 8D, CAPA, 5-Whys. Experience in 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 ISO13485 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 ISO13485 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 ISO13485-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 ISO13485 and ISO 14971 Advantageous Qualification in regulatory affairs or quality assurance Knowledge of MDSAP regulations If this sound like a good more »
Bishop's Stortford, Hertfordshire, South East, United Kingdom Hybrid / WFH Options
HR GO Recruitment - Bishop's Stortford
identification. Conduct quality audits across all organisations. Performance Measures: Maintain documented quality systems across the group. Support internal and external audits for compliance with ISO13485, 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 ISO13485 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, ISO13485, 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 ISO13485/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 ISO13485 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 »
CD methodologies Excellent problem-solving and communication skills Ability to work collaboratively in a fast-paced startup environment Desirable: Knowledge of or experience with ISO13485ISO 14971 Signal Processing Benefits: Competitive salary and equity options Flexible work arrangements Comprehensive health insurance Professional development opportunities Opportunity to more »
to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »
South West London, London, United Kingdom Hybrid / WFH Options
CURE TALENT LIMITED
to control other medical devices. Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO13485, 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 ISO13485 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) ISO13485 etc REF more »
Petersfield, Hampshire, South East, United Kingdom
Bennett and Game Recruitment LTD
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; ISO13485 & FDA guidelines CFR 21. Senior Hardware Design Engineer Position Requirements Minimum of 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 (ISO13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »
Chesterfield, Derbyshire, East Midlands, United Kingdom
Great Bear
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, ISO13485 and GDP requirements. Job responsibilities of a Quality Assurance Operative include: Record and distribute meeting minutes Ensure calibration records more »
Worcester, Worcestershire, West Midlands, United Kingdom
Probe UK
engineering or science to degree level (preferred) Experience in a quality related role. Ability to inspect and measure produced parts (with experience) Experience of ISO13485 or ISO 9001 Internal auditor qualification (preferred) Medical device manufacturing experience. Ability to communicate and liaise with different departments to ensure 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 ISO13485 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 ISO13485 standards. Proven experience in a quality assurance role, preferably within the distribution, logistics, or pharmaceutical sector. Exceptional attention more »
Royston, Hertfordshire, Melbourn, Cambridgeshire, United Kingdom
Polytec Personnel Ltd
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 »
Royston, Hertfordshire, South East, United Kingdom
Oho Group
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 »
Cambridge, Cambridgeshire, East Anglia, United Kingdom
Oho Group
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 »