1 to 8 of 8 ISO 13485 Jobs in the South East with Remote Work Options

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 »

identification. Conduct quality audits across all organisations. Performance Measures: Maintain documented quality systems across the group. Support internal and external audits for compliance with ISO 13485, UK MDR 2002, MDR 2017/745, MDD 93/42/EEC, MDSAP, and other regulations. Prepare and maintain QMS and … documentation. Assist QA Admin team with product approvals for UK and international markets. Evaluate suppliers and conduct approval audits. Document quality audits to meet ISO, UK, European and worldwide regulatory requirements. Facilitate quality improvement initiatives. Analyse data for management reviews and non-conformances. Conduct CAPA and non-conformance investigations. … Review customer complaints and maintain incident reporting. Meet LSAS objectives and targets. Core Competencies: Experience with BS EN ISO 13485 and global device directives/regulations. Maintain technical/design history files for compliance. Medical experience in a production/manufacturing environment. Internal and external quality auditing experience more »

products Excellent communication and interpersonal skills for client and colleague relationship-building Experience in team management (preferably Agile methodologies) BONUS POINTS FOR: Familiarity with ISO 9001 and ISO 13485 standards for medical device projects Background or experience with a design consultancy engineering environment Breadth of skills is more »

organisation whilst assisting meeting our regulatory responsibilities. Key duties: Implementation, maintenance, continuous improvement, and support of Blatchford’s Quality Management Systems (in line with ISO13485:2016) and the Medical Device Regulations). Collaboration across internal departments to provide Quality Assurance support. Participation in external Quality audit activities. Representing QA for … qualified or equivalent experience in similar role Internal audit qualification Demonstrated experience in a Quality Assurance role, which includes auditing. Good working knowledge of ISO 13485 (Desirable) Strong communicator with good interpersonal Highly analytical Able to assess information and data leading to rational judgements and successful conclusions. Ability 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 »

digital health apps deployed on mobile devices. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be 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 »