1 to 25 of 57 ISO 13485 Jobs in England

leadership skills and a desire to drive continuous improvement in quality processes. Key Responsibilities 1. Develop, implement, and maintain the QMS in accordance with ISO 9001, ISO 13485, UK MDR 2002 & (EU) MDR 2017/745. 2. Ensure compliance with applicable regulations and standards, including FDA regulations … years of experience in quality management within the medical device industry. Experience with implementing and maintaining Quality Management Systems (QMS) in accordance with ISO standards. · Knowledge of ISO Standards including ISO 13485, ISO 9001, ISO 14971, IEC 62304 and EN 60601. · Knowledge of global more »

manufacturing. Maintain accurate documentation and lab records. Introduce innovative technologies and make informed recommendations. Manage project scopes, resources, and budgets effectively. Ensure compliance with ISO 13485 standards. Requirements: Essential: Bachelor's degree or higher in a biological-related discipline, with significant post-qualification experience. Minimum of 3 years … experience in people management. Proven ability to lead, motivate, and mentor a team of scientists. Thorough understanding of product design control and ISO 13485 regulations. Extensive experience in molecular biology techniques such as FISH, PCR, DNA manipulation, and fluorescent labelling. Previous work in a regulated, diagnostic environment. Strong … software tools such as BLAST/BLAT and sequence searching methods. Comprehensive knowledge of genomic principles and databases. Additional management experience preferred. Experience in ISO 9001 and ISO 13485 compliant environments, including participation in audits. If you are ready to make a significant impact in a research more »

will be provided to assist carrying out these responsibilities. Main duties will include ? Generating usability documentation for regulatory submission of the product range with ISO practices. ? Leading , running and moderating use studies ? Working closely with the project and wider teams to create a device that meets the customers needs. … travel may be required Candidate Attributes ? Minimum of 2 years experience and relevant qualifications in usability and human factor engineering ? Practical experience ? Knowledge of ISO 13485 Practices. ? Experience in planning and conducting user studies ? Knowledge of use risk management processes ? Documentation writing skills and ability MS office programs … further information or call (01842) 820409 Skills Required Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical components, Qualifications Required ISO13485, Human factor, Usability, IEC62366 Keywords Engineer, communication skills, ISO 13485, Risk management, Travelling, Organise meetings, Medical Components/ more »

You’ll be responsible for supporting the compliance team to ensure all required certification is maintained. Complete internal audits in compliance with relevant standards (ISO 13485, 21 CFR, MDD/MDR and UKCA regulations) Assist in the logging, investigating, and documenting of all non-conformities Corrective and Preventative … someone with the following skills and experience; Ample experience in Quality Assurance specifically within medical devices Good knowledge of MDR is desired Knowledge of ISO 13485, ISO 9001 and knowledge of ISO 14001 is desirable Experience of Internal Audit, ideally as a lead auditor (desired) Experience more »

oversight of GMP and compliance within company operations, providing guidance on GMP, GDP and GLP ensuring compliance with internal and external requirements with both ISO 13485 and ISO 9001 standards. Requirements for this role: Degree in relevant biological discipline Significant experience within industry in similar role, within … ISO 13485 and ISO 9001 environments Experience with internal auditing Experience in manufacturing equipment validation Interviews are imminent so please apply now or contact Chris Morris at Science Solutions for more information. 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 »

be responsible for ensuring that the systems and processes in place for current Good Distribution Practice, MHRA guidelines, Home Office controlled drugs license and ISO-9001: 2015 and ISO 13485 standards are adhered to and that the procedures and appropriate training for the team and wider DD … Distribution Authorisation, GDP Guidelines 2013/C 343/01, Human Medicines Regulations 2021 relevant MHRA Guidelines, legal requirements, and updates Ensure compliance with ISO 9001: 2015 and ISO 13485: 2016 standards. Ensure the QMS is implemented and maintained. The RP must approve, sign and date, all … environment Minimum 2yrs experience in a quality managers/Management position Detailed knowledge and understanding of Medical Device legislation Good knowledge and understanding of ISO13485:2016 and associated standards Good working knowledge of product classification for medical devices, specifically selecting appropriate classification, and conformity assessment route. Formal Training in ISO13485 more »

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 ISO 13485 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 ISO 13485/9001) and other quality management systems (e.g., 27001) is highly desirable. Additionally, strong writing skills, teamwork abilities more »

We are seeking a talented Regulatory Affairs Specialist to join our client's regulatory team in support of the expansion of their ISO 13485 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, ISO 13485, and ISO 14971 * Excellent communication and writing skills * Strong team-working, analytical, and problem-solving skills * Ability to make decisions and more »

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, ISO 13485, TS16949, ISO 14004 - Previous quality management experience and completed successful improvement projects - Experience working in more »

based care. The concentration of the role is the production of software medical device technical documentation in compliance with the Medical Device Regulation and ISO 13485 (Medical Devices). Some input will also be required to support ongoing compliance with other ISO standards. Suitable candidates will have … Directive/Medical Device Regulation transition process. Up to-date working knowledge of the following: MDD and MDR (Class 1 & 11a devices); BS EN ISO 13485, 14971, 14155, 2700; BS EN IEC 606; BS EN 62304; NHS DCB0129/DCB0160 Additionally, you will have the following: Good working more »

Layered Process Audits and Finished Goods audits where necessary. • Ensure the auditing system is fit for purpose across the Quality Management System. Perform Internal ISO and Supplier Quality audits as necessary to ensure compliance with processes, policies, and expectations. • Lead and train others to develop effective corrective and preventive … suitability against the following essential and/or desirable relevant knowledge and experience: Essential: • Demonstrable knowledge and experience in an Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers, Supplier Management), plus having completed successful improvement more »

maintain process engineering area, ensuring that all automation equipment is catalogued and easy to allocate and access to jobs using WinMan Comply with all ISO 13485 requirements Experience Requirements: Industry recognized injection moulding qualifications (IMT Level 4 Advanced Processing preferable) Bachelors Degree in Electrical Engineering, Mechanical Engineering or … understanding of lean manufacturing principles and experience of implementation within an injection moulding facility Excellent communication skills Good project management skills Experience working to ISO 13485 an advantage Key Words: Process Engineer, Mould Process Engineer, Mould Process Technician, Process Automation Engineer, Automation Engineer, Injection Moulding, Plastics, Robotics, Automation more »

Aerospace etc.) Proven knowledge and experience of Change Control and Risk Management processes. Engineering or Scientific Degree is highly advantageous. Knowledge and experience of ISO 13485 & ISO 14971 is highly advantageous. If you're seeking an exciting opportunity to be part of a dynamic team driving medical more »

improvement tools and methodologies (Six Sigma, Mistake Proofing, Kaizen, etc). The Head of Quality Assurance & Testing Experience & Skills: Demonstrable knowledge and experience in ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, plus having completed successful improvement projects. Experience dealing with £multi more »

devices. Microsoft Azure certifications . Familiarity with FDA/MDR/UK MDR medical device software regulation is essential including applicable standards such as ISO 13485, ISO 14971, IEC 62304, IEC 82304, and IEC 62366. Deep understanding of software development lifecycle (SDLC) and best practices in the more »

our diagnostic outputs. Develop and deploy pipeline packages with robust, industry-standard codebases suitable for medical settings. Demonstrate familiarity with development standards such as ISO 13485 and Medical Devices regulations, ensuring compliance in product development. Requirements: Degree in computer science, mathematics, physics, or related fields, with 3+ years … context. Familiarity with model interpretation techniques is desirable. Track record of building and deploying pipeline packages with industry-standard codebases. Knowledge or experience with ISO 13485 and Medical Devices regulations is preferred. Passionate about the mission to transform microbiology diagnostics and combat antimicrobial resistance. Benefits: We offer competitive 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, ISO 13485, 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. Recent experience with NPI and ISO14001 Experience in Electronic Engineering Environment. Electronic Engineering Environment AS9100, ISO 9000, ISO 9001, ISO 13485, TS16949, ISO14001 previous Quality Management experience, (Automotive & Military Customers) Supplier Management), plus having completed successful improvement more »

development to launch and maintenance. Manage the engineering budget to achieve product goals. Implement a robust software development process compliant with medical device regulations (ISO 13485, ISO-IEC 62304). Champion information security (ISO 27001) through design, penetration testing, and secure coding practices. Lead product management more »

5+ years’ industry experience. Desirable: Previously involved in the development of wellness and/or medical devices. Experience coding to MISRA standards. Experience writing ISO 62304-compliant software (class A) under an ISO 13485 quality management system. Good understanding of wireless protocols, particularly Wi-Fi and Bluetooth. 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 »

NeuroTech AIMDs. Understands the end-to-end process for Class III Medical Devices. Has worked with contract manufacturers or built an internal manufacturing capability. ISO understanding across ISO 13485 requirements. How do I apply? To apply for this outstanding opportunity, please contact Nathan Sasso at Pivotal via more »

Minimum of 5 years’ experience in developing software and troubleshooting hardware issues. Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304. Significant experience in formal software verification Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »

op-amps, inductors etc.) Full product development life cycle experience from concept to release Non-Essential/Nice to have’s: Medical device standards (ISO13485, IEC 62304 etc.) Wireless technologies (Bluetooth/Wi-Fi etc.) Power Electronics Experience in a consultancy/start up environment Benefits: Profit share bonus more »