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 »
Cardiff, South Glamorgan, 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 »
scalable, allowing personalised therapies to be affordable for more people. To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of … all stakeholders. Requirements: Graduated with a bachelor's or master's in engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with "quality management … offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus. Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs/Herts Border Another top job from ECM, the high-tech recruitment experts. Even if 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 »
the business maintains and improves regulatory readiness through organic growth and future acquisitions.Be accountable and provide SME Quality advice whilst the business transitions into ISO13485 accreditation.Build and maintain strong relationships with the rest of the SLT and key stakeholders.Continuous improvement and updating of the Quality Management System Framework and Strategies … managerial responsibilities.Ideally knowledge/experience of complex products within instrumentation including software components/elements.Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards.Ability to collaborate and influence across multi-functional teams and stakeholders.Excellent verbal and written communication skills, and experience with technical writing including authoring and revising 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 »
similar. Experience in process and product validation (sterile packaging according to ISO 11607 would be advantageous). Understanding of a quality management system (ISO13485/FDA) and medical device manufacturing advantageous. Very good MS-Office skills, especially Excel. Strong organizational skills with the ability to communicate at all levels more »
book complying with GLP and GDP. Logging in of test samples. Preparing testing plans and data template ready for testing. Working within a controlled ISO13485 and ISO9001 Laboratory quality system and in accordance with GLP/GMP procedures. Design, plan and execute Physical testing in support of R&D activities … science related discipline. Experience in a working laboratory environment out with academia Understanding of compliance with FDA and European regulations relating to Quality Systems (ISO13485:2016, ISO9001:2000, FDA 21 CFR part 820) and GMP Guidelines and Regulation. Good working knowledge of Microsoft Office, specifically Word and Excel. Have an 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 »
