17 of 17 ISO 13485 Jobs in the South East

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 ❯

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 ❯

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 ❯

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 ❯

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 ❯

of electronics and software development methodologies will be needed embedded systems with RTOS a plus. Youll ensure the project adheres to Regulations and Standards (ISO13485, IEC 62304, FDA, CE Marking, etc) and Quality, and will keep abreast of Project Risks, Technical Documentation, and Project Tasks/Milestones. As well as More ❯

existing software in line with defined procedures. Ensure all activities undertaken are in compliance with company SOPs and Work Instructions and in accordance with ISO 13485 and CFR 820. Ensure the Service Desk Team Lead is made aware of key support issues and trends identified in the ITSM. More ❯

manual and automated testing, with knowledge of leading QA tools and frameworks. Experience working in regulated environments (e.g., digital health, SaMD) and familiarity with ISO 13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯

role with an innovative, growing company? Do you have experience with coordinating internal and external audits? Have you worked to industry standards such as ISO13485, AS9100 and ISO9001? If so, this Quality Systems Engineer position is perfect for you! This Quality Systems Engineer is working for an electronics manufacturer in … a full time on site role. The Quality Systems Engineer will support and develop the Business Management System, ensuring compliance with ISO9001, AS9100, and ISO13485 standards. Key responsibilities of the Quality Systems Engineer include document control, internal and external audit support and continuous improvement activities. The role involves coordinating external … ensuring effective system integration and compliance across operations. You will need: Experience with quality and business management systems Experience working to standards such as ISO13485, AS9100 and ISO9001 A background within manufacturing Internal auditing experience A degree or equivalent qualification in a relevant field is desirable Previous experience or knowledge More ❯

similar role. Training and experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDR, MDSAP). Lead audit trained in ISO13485/9001 Proven experience in relevant areas of Quality, Regulatory, or Engineering, preferably within a medical device environment. Strong written and verbal communication skills and More ❯

Web Apps and Functions Implement logging, monitoring, and alerting solutions for security events and system health Automate compliance checks and documentation for ISO27001 and ISO13485 requirements Collaborate with development teams to implement security best practices and DevSecOps processes Manage and maintain security protocols for handling sensitive healthcare data Required Qualifications … Azure Web Apps and Azure Functions Deep understanding of cloud security best practices and implementing Zero Trust architecture Experience with healthcare compliance requirements (ISO27001, ISO13485, HIPAA) and security controls Proven track record implementing automated security testing and vulnerability management Strong knowledge of monitoring and observability tools (Azure Monitor, Application Insights More ❯

Apply security-first development practices in all technical solutions Contribute to team culture through knowledge sharing and mentoring Help maintain compliance with ISO27001 and ISO13485 requirements Participate in technical discussions and architecture planning Required Experience: Strong experience with cloud services and implementing Software as a Service solutions, particularly with Azure … skills and ability to work effectively in a team Enthusiasm for learning and growing as a developer Familiarity with healthcare technology and regulatory requirements (ISO13485, ISO27001) Desired Skills: Experience in building mobile apps Experience working in a healthcare technology company Experience of penetration testing More ❯

will also support the development of engineering support departments through coaching, training, and mentoring. This role involves working in a regulated environment conforming to ISO13485, ISO14971, etc., with familiarity in Quality Assurance and Quality Control systems, medical device/pharmaceutical standards, FDA, GAMP, ISO, and international regulations. You will … communication to ensure improvement plans are followed Knowledge, Skills, and Abilities: Understanding of QA and QC systems, medical device/pharmaceutical standards, FDA, GAMP, ISO Experience with Manufacturing Process Systems, interfaces, and software validation Proficiency in PLC, SCADA programming (RSLogix500, Studio5000), and safety systems Experience with HMI applications, networks More ❯