51 to 73 of 73 Permanent ISO 13485 Jobs in the UK

s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO 13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »

functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO 13485, and IATF 16949, is a plus Experience working with suppliers and customers more »

the company's quality management system (QMS) to ensure compliance with regulatory requirements, including training and audits. Support in 3rd party audits according to ISO 13485 and QMSR requirements. Skills and Qualifications: Bachelor's degree in degree in a relevant scientific or engineering field; advanced degree preferred (e.g. 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 ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »

PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards Industry experience in a Quality role and in a Senior Leadership position (department head) Experience of running a medium-sized Life Science organisation Well 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 »

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 »

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 »

into the pharmaceutical market About Us: We are a specialized consultancy providing Regulatory Affairs support to the medical device industry. Our expertise spans across ISO 13485, European regulations, FDA regulations, and other global standards for medical devices. Join our team and be part of a growing consultancy where more »

Ideally, the Medical Devices company you have worked for has produced handheld or portable Medical Devices, but as long as the device is to ISO 13485 standards, we will consider your allocation. You will be rewarded with an excellent starting salary and package while being a part of 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 »

and Heidenheim controls. ?Undertake tool changes, offsets, and program editing ?Produce components to production deadlines ?Work to tight tolerances and strict quality standards (AS9001 & ISO 13485) ?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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »

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 »