City of London, England, United Kingdom Hybrid / WFH Options
Newton Colmore
Ideally, the Medical Devices company you have worked for has produced handheld or portable Medical Devices, but as long as the device is to ISO13485 standards, we will consider your allocation. You will be rewarded with an excellent starting salary and package while being a part of more »
Hands-on experience in electronics development within In Vitro Diagnostic (IVD) devices or a similar highly regulated industry. Strong understanding of relevant standards, including ISO13485, IEC 61010, and IEC 60601. Experience with: Motor control, including stepper and DC brushed motors. Temperature control using resistive heaters and Peltier devices. Optical systems 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 »
into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »
Royston, Hertfordshire, South East, United Kingdom
Vector Recruitment Ltd
and mechanical systems. Provide guidance to help develop and implement system improvements. Experience in writing, editing, or addressing product requirements. Previous experience working with ISO13485 beneficial. Sound like you or someone you know? If so, please do not hesitate to get in contact with Darren Holmes at Vector Recruitment Ltd more »
to reduce or mitigate any identified risks. Maintain knowledge of site policies and procedures, especially the quality system Develop and maintain working knowledge of ISO13485 & ISO9001, MDD/MDR, GDP, ISO27001 and LSAS requirements. Support regulatory and customer audits when delegated by the QA/RA Manager/Management representative … NC, CAPAs, Change Controls, Document updates, Risk Assessments. Support the internal audits/self inspection schedule and perform audits against cGDP and standards; ISO9001, ISO13485, ISO27001, ISO22301 & LSAS as the schedule dictates and maintain an inspection ready status. Perform local area and local system audits. Training/coaching of operations … a medical device or pharmaceutical quality function Qualified Internal Auditor Desirable: Good knowledge of the requirements of the MDD/MDR as well as ISO13485 & ISO9001 Ability to work in matrix teams. Experience of working with multiple QMS systems Understanding of the requirements of GDPR & ISO27001 Basic knowledge of the more »
Engineering) or equivalent (e.g Pharma, Biopharm, Life Science, Biotech) Good Experience in Quality Assurance; Problem Solving, Analytical and Continual Improvements. Certified Lead Auditor in ISO 9001:2015 or 13485:2015 Proven background leading and managing teams working with minimum supervision under pressure to tight deadlines with customer focus. more »
refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW 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 »
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 »
Worcester, Worcestershire, West Midlands, United Kingdom
Ernest Gordon Recruitment
on-Severn, Kidderminster, Great Malvern Are you a Quality Engineer from a manufacturing/medical background with extensive knowledge of ISO9001 or understanding of ISO13485 looking for your next step into a varied role with a market-leading company, where you will be the go to Quality expert that will … report correctly on all things Quality. This role would suit a Quality Engineer from a manufacturing or medical background with knowledge of ISO9001 or ISO13485 looking for an autonomous and technically challenging role within a well-established company offering support to further qualifications and opportunities for ongoing technical progression. THE … product auditing and product testing * Root cause analysis * Report correctly and support purchasing team THE PERSON: * Quality Engineer or similar * Knowledge of ISO9001 or ISO13485 * Quality qualifications * Manufacturing or Medical background * Commutable to Worcester Reference Number: BBBH13431 Key Words: QA, Quality, Assurance, Manager, Engineering, Medical, Implants, ISO9001, ISO13485, Worcester, Droitwich more »
Would you like to be part of a team helping to create something truly ground-breaking and game changing in the medical device industry? We have a world class diagnostic technology that enables rapid detection of respiratory viruses such as more »
