1 to 6 of 6 ISO 13485 Jobs in the Thames Valley

the ability to implement robust document control processes while working closely with the Head of Quality and Regulatory Affairs establish the QMS aligned with ISO 13485 requirements, driving continuous improvement and operation excellence. The successful candidate will also compile technical files with comprehensive documentation to support regulatory submission … and product certification while conducting risk management activities in accordance with ISO 14971, identifying potential hazards, assessing risks and implementing effective mitigation strategies. Quality and Regulatory Specialist Key Responsibilities: Manage and organize quality and regulatory documentation Ensure timely and accurate filing per industry standards Maintain compliance with regulatory requirements … regulatory affairs within the medical device industry, preferably with exposure to software (IEC 62304) and Software as a Medical Device (SaMD) Strong understanding of ISO 13485, ISO 14971, and other relevant regulatory standards Excellent communication skills with the ability to collaborate effectively across multidisciplinary teams Detail-oriented more »

primed for you as an individual who is well versed in Quality Engineering within the medical technology sector. Areas such as MDR, MDD and ISO 13485 will be second nature to you as this opportunity will allow you to be the subject matter expert for the business, to … week from home. What will you be doing as their next appointed Quality Systems Engineer? Perform internal quality audits in line with their accreditation (ISO 13485) against work instructions, manufacturing proceedures etc. Maintain and support their Improvement Culture, using your insight and analysis from performing audits as to … with other internal stakeholders on QMS related activities. Ready to apply? This is what you will need to demonstrate; Qualified/Certified Auditor for ISO 13485 (please note, this is a deal breaker for our client) Hands on knowledge of IS0 3485 i.e. you have worked in medical more »

Experience/Qualifications : Experience within the medical device industry, with knowledge of MDD 93/42/EEC, EU MDR (2017/745) and ISO 13485 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) ISO 13485 etc REF more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive 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 »