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 more »
and attention to detail Working knowledge of ISO9000/IATF16949 – a plus would be experience in a strong compliance industry such as AS9100 or ISO13485 Internal Auditor qualified or lead auditor preferred against ISO9000/IATF16949 Past experience in a similar role is key Previous experience in the semiconductor industry more »
Caernarfon, Gwynedd, Wales, United Kingdom Hybrid / WFH Options
Siemens Healthineers
professional and personal growth, all while valuing your unique contributions. Apply now for the position Quality Systems Engineer and you will ensure compliance with ISO13485, FDA 21 CFR Part 820 and other international regulatory requirements, and ensure business needs are met through the delivery and operation of vigilance and post 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 »
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 »
in electro-mechanical systems development for Class 2A/B medical devices will be pivotal as you ensure compliance with industry standards such as ISO13485 and 21CFR820. Beyond technical prowess, you'll play a key role in crafting meticulous documentation for regulatory submissions, supporting quality activities, and spearheading non-conformance … Experience required: Experience in Class 2A/B (is preferred) medical device especially in electro-mechanical systems development. Familiar with key standards such as ISO13485, IEC60601 and 21CFR820. Knowledge on IEC62304 is desirable. Some project management experience and knowledge on project management methodology. Essential skills: Leadership, application of engineering principles 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 »
