1 to 25 of 140 ISO 13485 Jobs in the UK

Manager Luton £45,000 - £60,000 + Training, Development, Progression Are you a passionate and experienced Quality Manager with a proven track record in ISO implementation? This is a great opportunity for a highly motivated individual with experience in quality engineering, ISO implementation and accreditation to tackle the … and existing product lines. Utilising tools like APQP, 8D, FMEA, and PPAP, along with your understanding of ISO9001, you'll contribute directly to gaining ISO accreditation and fostering a culture of continuous improvement. This is a great opportunity to join a growing and agile company, seeing huge growth in … the electronics manufacturing sector. The Role: *Quality Manager - ISO 9001, 13485 and 14001 * Lead and manage the implementation of ISO * Develop and maintain a comprehensive QMS, internal and external audits and quality documentation. * Collaborate with cross-functional teams, ensuring quality standards are integrated into all processes. Candidate More ❯

to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit … four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU … MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO More ❯

to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit … four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU … MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable skills: Work experience - Experience working with ISO More ❯

to audit and certify the quality management systems of the most innovative healthcare companies in the world Decompose, interpret and implement relevant quality requirements (ISO 13485, ISO 17021, EU MDR, ISO 42001, ISO 27001, etc.) Optimise the assessment of customer data by designing efficient audit … four years of professional experience in the field of medical devices Work experience - Minimum of two years of professional experience in quality management (e.g. ISO 13485, EU MDR, ISO 14971, etc.) Work experience - Experience auditing against medical device quality management requirements (e.g. ISO 13485, EU … MDR, ISO 14971, etc.) Technical experience - Minimum one year of practical experience working with medical device software, demonstrating knowledge of relevant requirements (e.g. IEC 62304, IEC 82304, etc.), software development methodologies, cyber security, and one or more programming languages Desirable Skills Work experience - Experience working with ISO More ❯

Software Engineer, Quality, IEC 62304, ISO 13485, Medical Devices, COR7184 A rare and exciting opportunity has arisen for a Software Engineer with experience working with software as a medical devices and IEC 62304 standards, to join a pioneering scientific R&D company specialising in the development of medical … Diagnostic products. Working alongside a highly skilled team, you’ll be responsible for implementing and maintaining SDLC processes, software risk management, and compliance with ISO 13485, IEC 62304, and 21 CFR Part 820. This is a fantastic opportunity to make a significant impact in a fast-growing company … Engineer? Experience defining, implementing, and maintaining Software Development Life Cycle (SDLC) processes Proven experience in software quality engineering and risk management Strong knowledge of ISO 13485, IEC 62304, 21 CFR Part 820, IVDR Experience in software security risk management (SW:96:2023, ISO 27001, IEC 80001) is More ❯

+ Training, Development, Progression About the Role Are you a passionate and experienced Quality Manager with a proven track record in ISO implementation? This is a great opportunity for a highly motivated individual with experience in quality engineering, ISO implementation, and accreditation to build a new quality department. … Support both new and existing product lines with quality control, inspection, and process improvements. Utilize tools like APQP, 8D, FMEA, and PPAP. Contribute to ISO 9001 accreditation and foster continuous improvement culture. Key Requirements Proven experience leading ISO implementation (ISO 9001, 13485, 14001). Knowledge of … have a valid UK work permit. By applying, you confirm you have no criminal record and are legally eligible for employment. Keywords: Quality Manager, ISO Implementation, ISO 9001, ISO 13485, ISO 14001, Quality Engineer, ISO Standards, Auditing, Continuous Improvement, Electronics, High-Tech, Manufacturing, Bedfordshire More ❯

within budget, and aligned with the company's objectives. Regulatory Compliance & Standards: Stay up-to-date with industry standards, best practices, and regulatory requirements (ISO 13485, ISO 24971, 21 CFR 820.30, MDR, EN 13554, IEC 60601, ISO 10993). Implement necessary changes and improvements within device … Proven expertise in device design and development, ideally with experience in handheld nebuliser or smart inhaler devices. In-depth knowledge of relevant regulatory standards (ISO 13485, ISO 24971, 21 CFR 820.30, MDR, EN 13554, IEC 60601, ISO 10993). Strong project management skills, with experience leading More ❯

support the Head of QA, responsible person and responsible personfor import, in the implementation and maintenance of the Quality Management System in accordance with ISO 9001 and ISO 13485 standards, and in compliance with EU GDP guidelines. Ideally you will have experience of working in a GMDP … Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. … Quality System Management Reviews, including the preparation of meeting inputs, attendance and presentation at meetings and the management of the meetings outputs. Supporting Regulatory, ISO and Client audits, and conducting Supplier audits, internal audits, and self inspections, including the preparation of responses and CAPA plans. Key Skills/Experience More ❯

authorities. To ensure that products conform with relevant regulations in territories in which they are sold; OND and ONT operate two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT). Reporting and providing primary support to the Head of QA, the role of the Associate Director … as directed) in any matter. • All activities required to help ensure the QA team achieve their annual objectives and maintain/sustain the ISO9001 & 13485 accreditation. This may require the role to fulfill part of the role of "Person with Responsibility for Regulatory Compliance" as per the EU IVDR. … highly desired. Understanding or experience of computer systems validation is desirable (e.g. GAMP5). Knowledge/Skills/Abilities Essential: Detailed working knowledge of ISO13485, MDSAP requirements and the IVDR are essential. Demonstrable experience of working with external partners and stakeholders, showing a balanced level of discretion and sensitivity to More ❯

of life-saving medical technology, ZiO Health is the place for you. Responsibilities Lead, implement and maintain the Quality Management System in line with ISO 13485 requirements throughout the organization. Implement and oversee the company's Risk Management processes in line with ISO 14971 requirements. Define quality … a Quality Engineering, Quality Assurance or Regulatory role with medical devices. Knowledge and experience in medical device Quality Management Systems and regulatory processes including ISO 13485, ISO 14971, ISO 27001, 21 CFR Part 11, 21 CFR Part 820, MDR 2017/745, IEC 62304. Proven track More ❯

ability to clearly present technical data and collaborate cross-functionally. Familiarity with regulatory standards, including EU MDR (Regulation 2017/745), 21 CFR 820, ISO 13485, and ISO 14971. Excellent project and time management skills. Proven ability to work collaboratively within cross-functional teams while also demonstrating … initiative and self-direction to work independently with minimal supervision when required. Desirable: Certification in Quality Management Systems (e.g., ISO 13485, ISO 9001, ASQ, Lead Auditor). Six Sigma Green or Black Belt certification, or equivalent experience in statistical analysis. Experience in a medical device or life More ❯

Documentation & Submissions: Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews. Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards. Risk Management: Lead and coordinate risk management activities in accordance with ISO … improving lives through assistive technology. Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations. Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series. Experience with Class I medical devices and SaMD regulatory requirements. Excellent documentation and More ❯

Documentation & Submissions Prepare and maintain regulatory submissions and documentation including Declarations of Conformity, Technical Files and labelling reviews. Ensure documentation is in compliance with ISO 13485, IEC 62304, ISO 14971, and other applicable standards. Risk Management Lead and coordinate risk management activities in accordance with ISO … improving lives through assistive technology. Strong working knowledge of UK MDR, EU MDR, and FDA medical device regulations. Familiarity with technical standards such as ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series. Experience with Class I medical devices and SaMD regulatory requirements. Excellent documentation and More ❯

journey within Hologic, this role offers the chance to lead quality assurance through meaningful growth and transformation. About the role: Endomag is certified to ISO 13485, MDSAP, EU MDR and has CE certification for a Class IIa, IIb and III medical devices. The job holder will lead our … and processes by enforcing quality standards and regulations and testing of materials and products by our virtual supply chain. Maintain the company’s MDR ISO 13485/MDSAP quality system and CE certification. Represent the company during audits by its Notified Body or other organisations Lead the QMS … eQMS systems Lead Auditor experience Experience of direct interaction with regulatory authorities would be desirable Full understanding of the ethos and 8 principles of ISO13485 Understanding and working knowledge of ISO14971 Quality and Process knowledge/experience around material and sterilisation compatibility processes. ISO10993, ISO11135, ISO11737 Knowledge and understanding of More ❯

under DCB 0129/0160 , leading safety governance and documentation (e.g. safety case reports, hazard logs) Develop and manage risk management plans aligned with ISO 14971 , ISO 13485 , and support submissions under UK/EU MDR Lead incident investigation, adverse event reporting, and CAPAs Chair hazard workshops … PhD) with NHS CSO certification 3+ years experience in a clinical safety role (preferably in digital health) Strong understanding of DCB 0129/0160 , ISO 14971 , ISO 13485 , and UK/EU MDR Excellent communication skills; comfortable working across technical and non-clinical teams (Desirable) Experience in More ❯

join a leading pharmaceutica logistics company. This role focuses on supporting the implementation and maintenance of the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 standards, and ensuring compliance with EU GDP guidelines. Key Responsibilities: Maintaining and enhancing the QMS to meet regulatory … ISO, and client requirements. Supporting audits (regulatory, ISO, client, supplier) and managing CAPA plans. Driving a culture of quality excellence across the business. Conducting supplier audits, internal inspections, and management reviews. Key Requirements: Proven experience in a GMDP or similar regulated environment. Strong knowledge of GDP, GMP, ISO 9001, and ISO 13485 standards. Excellent organizational, communication, and stakeholder management skills. A positive attitude toward promoting quality across all departments. Proficiency in MS Office applications (Word, Excel, PowerPoint, Teams). If you have the skillset required and looking for your next career move, please apply for More ❯

and support the Head of QA and other key personnel in maintaining and implementing the Quality Management System. This will be in line with ISO 9001 and ISO 13485 standards and in compliance with EU GDP guidelines. Ideally, you will have experience working in a GMDP environment … improving quality systems across the business. Key Responsibilities: Assist in the implementation and upkeep of the Quality Management System, adhering to GMP, GDP, and ISO standards. Ensure ongoing compliance with industry standards, regulations, and company policies. Foster a positive quality culture within the organization, supporting continuous improvement efforts. Contribute … to Quality System Management Reviews, preparing inputs, attending, presenting at meetings, and managing outcomes. Participate in audits (Regulatory, ISO, Client, Supplier, and internal) and manage CAPA plans. Skills and Experience: Proven experience and good working knowledge of GDP, GMP, and GPhC regulations, as well as ISO 9001 and More ❯

and products for research use only (RUO) and IVD instruments, which are subject to regulations in various territories. ONT operates two Quality Management Systems (ISO 13485-OND & ISO 9001-ONT) to ensure compliance. Reporting to the Head of QA, the Associate Director of Quality Assurance is responsible … but are not limited to: Acting as support and senior deputy to the Head of QA. Ensuring achievement of annual objectives and maintaining ISO9001 & 13485 accreditation, including regulatory compliance roles such as EU IVDR. Building strong cross-functional relationships to facilitate best practices in risk management, product development, manufacturing … leading certification audits is essential. Desirable experience includes FDA inspections, recalls management, and computer systems validation. Knowledge/Skills/Abilities Deep knowledge of ISO13485, MDSAP, IVDR, and related standards. Strong stakeholder management, regulatory understanding, and ability to simplify complex standards for team implementation. Excellent interpersonal, organizational, and influencing skills More ❯

regulatory team to ensure customer complaints, feedback, incidents and notifiable events are handled in compliance with the company’s SOPs for post-market surveillance, ISO 13485 and EU MDR Working closely with supply chain, customer success, and commercial teams to ensure a positive customer experience Skills & Competencies Essential … in a role with significant levels of contact with external parties such as customers or suppliers Desirable: Experience working within a quality management system (ISO 13485 or ISO 9001) or in a regulated industry Familiarity working with ERP systems Experience working with CRM systems Experience working primarily More ❯

align on deliverables and be key in delivering to multiple business units Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001) Requirements ️ We want to hear from you if you Have experience in the following tech stack: Backend: Nodejs, JavaScript … with internal and external stakeholders Good communication skills Collaborative and willing to listen to others ideas Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS More ❯

align on deliverables and be key in delivering to multiple business units. Being fully aware of our ways of working - within our regulatory standards (ISO 13485, ISO 27001). ️ We want to hear from you if you Have experience in the following tech stack: Backend: Nodejs, JavaScript … with internal and external stakeholders. Good communication skills. Collaborative and willing to listen to others ideas. Skin Analytics manufactures medical devices and complies with ISO standards 13485 and 27001. As part of your employment, you will be assigned Quality Management System (QMS) and Information Security Management System (ISMS More ❯

Develop and present tailored proposals, RFP responses. Negotiate enterprise-level contracts for multilingual content workflows. Ensure agreements align with industry regulations and quality standards (ISO 13485, ISO 9001, ISO 27001). Cross-Functional Collaboration Work closely with project managers and quality assurance teams to deliver high More ❯

this role, you have the opportunity to Be involved in the development of Philips CDS software, within the Tools team. In compliance with the ISO standards applied to the medical sector (ISO 13485), you will participate in the creation of tools used by our development teams. You … responsable du développement, vous intervenez sur le développement des logiciels de Capsule Technologie au sein de l'équipe Tools. Dans le respect des normes ISO appliquées au médical (ISO 13485), vous participerez à la réalisation des outils utilisés par nos équipes de développement. Vous proposez un design More ❯

Location: London (on-site 4 days/week) Salary: Dependent on experience + benefits Responsibilities Develop, implement, and maintain software QA processes compliant with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification activities, including test planning, execution, and documentation. … Collaborate with software engineers to ensure SDLC compliance, including risk management (ISO 14971) and cybersecurity. Support regulatory submissions by preparing documentation such as Software Development Plans, DHF, and SBOM. Address and document non-conformances, CAPAs, and audits related to software. Skills & Experience Experience in QA/RA for medical … device software or related fields. Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations. Experience with software validation, V&V testing, and risk management (ISO 14971). Familiarity with configuration management, cybersecurity standards, and AI/ML regulations is a More ❯

in our medical technology meets the highest quality and regulatory standards. Responsibilities: Develop, implement, and maintain software quality assurance (QA) processes in compliance with ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR. Lead software validation and verification (V&V) activities, including test planning, execution … and documentation. Collaborate with software engineers to ensure software development lifecycle (SDLC) compliance, including risk management (ISO 14971) and cybersecurity considerations. Support regulatory submissions (e.g., FDA 510(k), CE marking) by preparing software-related documentation such as Software Development Plans, Software Design History Files (DHF), and Software Bill of … effectively addressed and documented. Skills & Experience: Demonstrable experience in QA/RA for software in medical devices or a related field Strong knowledge of ISO 13485, IEC 62304, FDA 21 CFR Part 820, and EU MDR regulations for software Experience with software validation, V&V testing, and risk More ❯