Experience working with early-stage products. Experience developing approval ready devices and products. Experience with C++ & C also useful. Experience within Medical Devices Sector (ISO13485). If interested, please apply, or reach out for further information about the role more »
industry. - Familiarity with ISO 9001, ISO13485, GCP is essential. - Knowledge of ISO 21CFR Part 820, ISO17025, Clinical Trials experience, ISO13485 Lead auditor would be beneficial. Interested or know someone who might be? Reach out to Ben Godley using the following: ✉️ 📞 01892 362010 Apply now: If more »
all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »
Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »
Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
intent and operational workflow of designed electronic systems to product engineering staff. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. From an educational perspective, you will be degree qualified in electronic engineering or a related field. Life at … analysis using modelling (Cadence and Xilinx) and experimental/prototyping methods Experience in DFx (design for manufacturing, assembly and test) Knowledge and appreciation of ISO13485 and FDA Medical Device Design Control Mentoring/leadership experience or strong potential/natural next step What next? We believe the key to unlocking more »
. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant 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 »
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 »
maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up more »
laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance 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 »
least one of: electronic devices, embedded software, or application software Proven years direct project management experience Proven record of successful project management within an ISO13485 or similar quality system Proven ability to deliver results through others, both direct and matrixed. Proven ability to build/lead dedicated, passionate teams. Can more »
Cardiff, Wales, United Kingdom Hybrid / WFH Options
Gyrus Medical Ltd An ATL Technology Company
advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality … orientated qualification Minimum of 3 years experience working in a QA/QS environment, preferably within the medical device or pharmaceutical industry. Knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC Knowledge of FDA QSR Part 820 Computer literate to include MS Word, Excel and more »
Knaresborough, North Yorkshire, Yorkshire, United Kingdom
Travail Employment Group
and Heidenheim controls. ?Undertake tool changes, offsets, and program editing ?Produce components to production deadlines ?Work to tight tolerances and strict quality standards (AS9001 & ISO13485) ?Working a rotational shift of earlies and lates as follows: o6am - 2 Mon - Thurs, 12.30 finish on Fridays o2pm to 12.30 Mon 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 »
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 »
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 »
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 »
Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
the continued performance, safety and reliability of our products. We would love to hear from people who are familiar with industry standards such as ISO13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »
activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering more »
report Skills and experience required: + Degree in relevant discipline + Proven experience in medical device development + Previously worked to relevant quality standards – ISO13485 + Experience in prototyping and testing + Strong 3D CAD skills + Experience in different manufacturing processes - injection moulding The salary will more »
Rosyth, Scotland, United Kingdom Hybrid / WFH Options
Optos
to tight deadlines and be able to manage your own time well. It would also be great if you have experience of working with ISO13485 and FDA Medical Device Design Control processes. Life at Optos is fast-paced and everyone tends to chip in. We have an experienced team who more »
and supporting the operation in the maintenance of quality. Maintaining a thorough working knowledge of practices, procurement, licensing, and regulatory requirements (IVDR, UK MDR, ISO13485) in all areas associated within Pathology and in particular relating to design, development, manufacture and testing of NHSBT produced reagents. Having expert knowledge in in more »
products and design new ones Lead presentations and liaise with senior management on a daily basis Have a good understanding of IEC60601 family standards, ISO13485, ISO14971 and BSEN62304 This is a highly varied, challenging and interesting role with an employer of choice in Caerphilly. Not only will you benefit from more »
Test Engineer Petersfield GU32 £17.00p/h We are recruiting for a Test Engineer for one of our clients based in Petersfield. The company is a family run company that work on medical and defence equipment. This is an ongoing more »