Systems Engineering or related engineering field. At least 10 years' experience in health-care or molecular engineering with demonstrated experience with FDA QSR and ISO 13485. Experience developing products in an IVD diagnostic development, including use of Statistics in experimental design. Strong understanding of mechanical, electronic and software design 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 ❯
by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001. Who we're looking for Dot Compliance is a leading provider of cloud Quality and Compliance management solutions 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 ❯
audit inspections. Main duties and responsibilities Ensure that the Zot Integrated Management Systems is operating consistently and effectively to the requirements of: ISO9001, AS9100 , ISO13485 ISO14001 Provide training, where appropriate, on new changing procedures Ensure Quality Management Systems are maintained and improved. Q-Pulse Administration Manage the Calibration process. Manage … role of Management Representative by top management of Zot Engineering Ltd. and fulfill the requirements specifically but not limited to the standards noted below: ISO13485 Ensure that processes needed for the quality management system are documented. Report to top management on the effectiveness of the quality management system and any 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 ❯
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 ❯
