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 ISO13485, GDPR, and HIPAA. Strong passion for quality and software craftsmanship, with a practical and resourceful mindset. Experience mentoring and collaborating with peers More ❯
and reliable medical devices. Responsibilities: Software Development: Design and develop software for medical devices while ensuring compliance with industry standards such as IEC 62304, ISO 14971, IEC 62366, IEC 13485, and FDA regulations, including cybersecurity requirements Implementation & Compliance: Develop software solutions and support cross-functional development activities, ensuring More ❯
/or presentations at conferences Experience with data management, for example using Excel, R or SQL 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 ❯
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 ❯
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 ❯
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 ❯
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 ❯
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 ❯
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 ❯
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 ❯
