Slough, Berkshire, South East, United Kingdom Hybrid / WFH Options
Orion Electrotech Professional Engineering
primed for you as an individual who is well versed in Quality Engineering within the medical technology sector. Areas such as MDR, MDD and ISO13485 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 (ISO13485) 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 ISO13485 (please note, this is a deal breaker for our client) Hands on knowledge of IS0 3485 i.e. you have worked in medical more »
Oxford, Oxfordshire, South East, United Kingdom Hybrid / WFH Options
Bond Williams Limited
of design and development documentation across various platforms. In this role, you'll offer documentation support for both new and existing projects within the ISO 9001 and ISO13485 Quality Management Systems. We're looking for someone with a demonstrated track record in maintaining documentation within quality … technical documentation role, with expertise in administering technical/quality documentation that may be subject to audit or inspection by external bodies. Familiarity with ISO standards (particularly ISO13485/9001) and other quality management systems (e.g., 27001) is highly desirable. Additionally, strong writing skills, teamwork abilities more »
Milton Keynes, Buckinghamshire, South East, United Kingdom
Redline Group Ltd
organisation The Head of Quality Job, based in Milton Keynes, will require the candidate to: - Knowledge and experience in an Electronics Engineering Environment AS1900, ISO 9000, ISO 9001, ISO13485, TS16949, ISO 14004 - Previous quality management experience and completed successful improvement projects - Experience working in more »
We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO13485 diagnostics product pipeline. Reporting to the Regulatory Affairs Manager, you will play a crucial role in ensuring regulatory compliance and supporting the successful submission … biomedical sciences) * Two or more years of experience in regulatory affairs within the diagnostics or medical devices industry * Strong knowledge of FDA, EU regulations, ISO13485, and ISO 14971 * Excellent communication and writing skills * Strong team-working, analytical, and problem-solving skills * Ability to make decisions and more »
the Head of Quality: Strong leadership and mentoring skills. Experience in Electronic Engineering Environment. Demonstrable knowledge and experience in an Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement more »
the Head of Quality: Strong leadership and mentoring skills. Experience in Electronic Engineering Environment. Demonstrable knowledge and experience in an Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement more »
as part of EMC testing when required. The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities. Skills, Experience & Qualifications: Proven track record in … implementation, and validation of electronics for medical devices or other complex high integrity products. Proven track record of electronics design and development compliant with ISO13485 and ISO 14971. Familiarity with the regulatory requirements for electrical safety for compliance with European, Canadian and United States quality standards … with practical working knowledge of IEC 60601 and ISO 13485. Experience of version control systems (Altium, PDM) for electronics design highly desirable. Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English Enthusiasm, good communication skills and ability to work more »
Didcot, Oxfordshire, South East, United Kingdom Hybrid / WFH Options
Professional Technical Ltd
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 ISO13485 standards for medical device projects Background or experience with a design consultancy engineering environment Breadth of skills is more »
Oxford, Oxfordshire, South East, United Kingdom Hybrid / WFH Options
Orion Electrotech Design
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
Oxfordshire, England, United Kingdom Hybrid / WFH Options
Orion Electrotech
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
Experience operating in ISO9001 environment Excellent working knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory … Specialist, Quality Assurance Manager, QA Manager, ISO9001, ISO13485 Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency more »
To ensure that the project information is well maintained; for example, budget costs, folders, linked projects To ensure compliance to FDA/NPMA/ISO13485, as well as supporting Medical Device Directive/Regulations documentation Desirable Experience/Qualifications: Degree within project management or a related field more »
Looking For: * Minimum 3 years of experience in regulatory affairs within the diagnostics industry. * Strong knowledge of IVD device regulations, including 21CFR, IVDR, and ISO 13485. * Excellent communication, writing, and problem-solving skills. * Ability to work effectively in multidisciplinary teams and make informed decisions. * Understanding of when to escalate more »
Engineer, Berkshire: - Experienced in mechanical and electrical testing - Experience in both hands-on testing and documentation writing - Experience in highly regulated industries - Experience of ISO13485 is highly desirable For more information or to apply for the Contract Verification Engineer opportunity based in Berkshire, please contact Jack Kelly -/ more »