1 to 25 of 43 Permanent 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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO 13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers 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 ❯

Expertise in plastics materials and processing (e.g., injection molding, extrusion, ultrasonic welding, UV/solvent bonding, sterilization). Knowledge of FDA Design Controls and ISO 13485 Quality Management Systems. Proficiency in CAD design and PDM software (e.g., Creo, SolidWorks). Understanding of ANSI/AAMI/ISO 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 ❯

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 ❯

both customer-provided and Plexus-developed test solutions. Defining and supporting calibration and preventative maintenance processes. Validating test systems/fixtures for compliance with ISO 13485 and FDA 21 CFR 820 standards. Performing failure analysis and yield improvement actions on PCBAs and complete end products. Utilizing problem-solving More ❯

all Supplier generated design changes are managed and documented in a compliant manner. Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 13485 requirements during day to day and assigned audit/CAPA activities. Maintain a good level of housekeeping in designated areas and observe … experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc. Strong … sound judgment is highly desired. Understanding of the NPI (New Product Introduction) process and Process Validation is preferred. A thorough understanding of GMP/ISO regulations and validation regulations is preferred. Strong mentoring, coaching and leadership skills are required. Demonstrated project management and project leadership abilities. Rewards & Benefits TCS More ❯

the business working closely with staff at all levels of the organisation. You will take a prominent role leading/driving internal and external ISO 13485 and MHRA audits. There are a number of key projects led and supported by the quality team that need to be delivered … or pharmaceutical Quality Assurance, Senior Quality Assurance, Principal Quality Assurance Engineers or QA Specialists. All candidates should have strong experience leading or closely supporting ISO13485/MHRA audits, driving QA projects across a business and leading/coaching/mentoring junior colleagues in the QA function. Exposure to leading or More ❯