1 to 25 of 48 ISO 13485 Jobs in the UK excluding London

supporting their commitment to quality, compliance, and continuous improvement, helping to safeguard the integrity of their products and processes. Drawing on your expertise in ISO 17025 and wider regulatory frameworks, you will take ownership of their Business System Manuals and Technical Documentation, ensuring they remain robust, up to date … and audit ready. As the Management Representative for ISO 13485:2016, you will lead internal audits, monitor regulatory changes, and drive compliance initiatives across the business, working closely with teams to embed quality and regulatory best practices into everything they do. Whether maintaining technical documentation, leading management reviews … of all in-vitro diagnostic medical devices manufactured and sold by our client and manage all technical documentation. To act as management representative for ISO 13485:2016. Requirements for this role: Demonstrable experience of ISO 17025 accreditation within a laboratory environment. Experience of ISO 9001, ISO More ❯

This role requires strong analytical skills, coordination capabilities, and a deep understanding of software testing methodologies. Additionally, this role will encompass software validation to ISO 13485, ensuring compliance with medical device software quality standards. KEY ACTIVITIES Develop, implement, and manage test strategies, plans, and cases to ensure comprehensive … collaboration with business and technical stakeholders. Identify risks and create mitigation plans to ensure smooth test execution. Ensure that software validation activities comply with ISO 13485 and other relevant regulatory requirements. Test Execution & Management: Identify responsible parties for testing processes across the business and work with them to … of Agile and DevOps methodologies. Strong analytical, problem-solving, and decision-making skills. Excellent communication and stakeholder management abilities. Experience with software validation to ISO 13485 or other regulated environments. ISTQB or other relevant testing certifications. Bachelor's degree in Computer Science, Information Technology, or a related field 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 ❯

role, you will play a key part in our Quality Team, reporting to the Head of Quality, responsible for maintaining the quality system to ISO 13485 standards and associated product certification. Responsibilities: Support the maintenance and continuous improvement of our ISO 13485 compliant Quality Management System … to process improvements. Required Experience: At least 2 years of experience in a Quality role within the medical device industry. Hands-on knowledge of ISO 13485 and 21 CFR 820. Strong attention to detail and problem-solving skills. Ability to work effectively in a multidisciplinary, fast-paced, diverse More ❯

implementation of the Business Management System (BMS), lead internal audits, support external compliance requirements, and champion best practice aligned to industry standards such as ISO 9001, ISO 13485, and AS 9100. Key Responsibilities Develop and maintain the company's Business Management System and digital platforms in line … ll Bring 3+ years of quality systems experience within a manufacturing setting (medical, aerospace, automotive, or similar). Certified or experienced internal auditor for ISO 9001, ISO 13485, or AS 9100. Excellent knowledge of quality standards and good documentation practices. Strong interpersonal and analytical skills, with a 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 ❯

An interest in healthcare, software, or quality/compliance - A degree (or equivalent), or relevant experience in administration, finance, or customer support - Experience with ISO-certified systems (such as ISO 13485, ISO 27001, or ISO 9001) is desirable This role might particularly suit someone with More ❯

days a week) Salary: Dependant on experience + Excellent benefits 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 Materials … 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 ❯

seeking to recruit an experienced Quality Systems Engineer to complement their professional Quality Division. Reporting to the Quality Manager and working in an ISO9001, ISO13485, ISO14001 and IATF16949 accredited environment based near Dudley, the successful candidate will be tasked with developing the Quality strategy, policies, processes, standards and systems within … of quality and business systems and strong knowledge of IMDS, APQP, PPAP and FMEA, along with Lean Manufacturing/Six sigma and ITAF 16949, ISO 13485, ISO 9000, gained within a high volume manufacturing environment. You will demonstrate a good understanding of engineering drawings and manufacturing processes … measurement and quality assurance, with knowledge of both ISO 27001 and ISO14001 and Health and Safety Practices gained in an automotive environment proving distinctly advantageous. Contact the Quality Team at Premier Technical Recruitment on 01827 68400 or email your cv in confidence to for further details. More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

CANDIDATE WILL HAVE A background in product design and/or engineering, ideally including the development of diagnostic medical devices Experience of working to ISO 9001 and ISO 13485 standards ABOUT US At Oxford Product Design (OPD) we’re on a mission to make things better. Better More ❯

Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯

Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯

Experience with IOT technologies & common network protocols (Wi-Fi/BLE/MQTT/etc) Experience of working within a Quality System ideally EN ISO 13485 or ISO 9001 and awareness of validation and verification procedures. Qualifications & Professional Experience : Degree in Electronics Engineering. At least More ❯

the release process. Ensure compliance with regulatory or internal change management policies, including experience with standards surrounding software as a medical device, for example ISO 13485 and ISO 62304. Test Automation Maintain best practices for release management, such as CI/CD (Continuous Integration/Continuous Deployment More ❯

collaborating with internal teams and external stakeholders. Key Responsibilities Support the ongoing development and implementation of the Business Management System Ensure documentation complies with ISO 9001, AS 9100, ISO 13485, and related standards Lead internal audits and support external audit processes Contribute to document control and updates … Assist in quality reviews and data analysis The Person Experience in quality management within industrial or manufacturing settings In-depth knowledge of ISO9001, AS9100, ISO13485, and ideally ISO14001 Internal auditor qualification and audit experience Strong analytical and problem-solving abilities Confident working across teams and with external bodies Proficient in More ❯

this role, you'll ensure the business runs smoothly by keeping systems up to date, supporting audits, and helping meet high industry standards like ISO 9001, AS9100, and ISO 13485 . You'll work closely with different teams, take part in audits, and help solve problems using … For Essential: 3+ years in a quality role within manufacturing (preferably medical, aerospace, automotive, or similar). Experience with quality standards like ISO9001, AS9100, ISO13485, ISO14001 . Strong audit skills ideally certified or qualified in internal auditing. Desirable: Degree in Mechanical or Electrical Engineering (or similar). Hands-on knowledge More ❯

of electronics, including the ability to read schematics and use test equipment like digital voltmeters and oscilloscopes. Familiarity with medical device regulatory standards (e.g., ISO 13485, FDA guidelines) is highly preferred. More ❯

experience) A shown level of experience in the project management of IVD device product development from initial development through to launch. Knowledge of ISO9001, ISO13485/CE marking. Knowledge of GAMP5, IEC62304 & ISO14971 would be highly desirable. Experience working collaboratively with a wide range of partner teams across the business More ❯

Prototyping : Hands-on experience with miniaturization, waterproofing, and creating robust electronics for wearable devices. MedTech Regulatory Standards : Knowledge of medical device regulatory standards (e.g., ISO 13485, FDA) and experience in compliance testing. Sensor Integration : Familiarity with various biosensor technologies, including electrochemical sensors used in wearable health devices. Wearable More ❯

support process development initiatives. Key responsibilities: Design, develop, and optimize manufacturing processes for transfer project. Conduct process validations and ensure compliance with FDA and ISO regulations. Draft and execute IQ, OQ, PQ in cleanroom environment Collaborate with product development teams to ensure the manufacturability of new products. Monitor and … understanding of manufacturing processes in MedTech industry, including injection molding, CNC, assembly, and sterilization. Knowledge of quality management systems and regulatory requirements (e.g., FDA, ISO 13485). Proficiency in statistical analysis and process improvement methodologies, such as Lean and Six Sigma. Ability to interpret engineering drawings and technical More ❯

noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯

noise reduction, spectral analysis). Comfortable navigating noisy real-world datasets and sensor limitations. Experience working within or adjacent to regulated medical environments (e.g. ISO 13485, MDR) is a bonus. A natural collaborator and communicator, able to bridge technical and clinical perspectives. Following your application, Mark Njiriri , a More ❯