Software Quality Assurance Specialist
We are looking for a skilled professional to ensure the highest standards of quality and compliance in software development.
* The successful candidate will lead the establishment and implementation of compliant Quality Assurance processes, overseeing design, development, validation, and clinical application of advanced medical systems.
* Responsibilities include serving as the Quality representative for Design Control, providing expert quality support for Software design and development, maintaining a compliant Bug Tracking System, and guiding Software Teams in adhering to industry standards and regulatory guidelines.
* The ideal candidate will have expertise in FDA software validation, Cybersecurity, and IEC 62304 Software Lifecycle process standards, as well as strong knowledge of ISO 14971 (Risk Management for Medical Devices) and experience applying usability engineering principles in accordance with IEC 62366-1.
* A Master's degree in Life Sciences, Engineering, or a related field is required, along with 3 to 5 years of relevant industry experience in medical devices, preferably Class III (MDR) or Active Implantable Medical Devices (AIMD).
* Additional skills include proficiency in medical device documentation and compliance with industry standards and guidelines, hands-on experience with software testing, build automation environments, and CI/CD pipelines, and programming experience with one or more languages: Embedded C, C++, Kotlin, Java, and Python.
About You
We are seeking a results-driven, detail-oriented individual with a strong drive for precision and consistency, high integrity, and commitment to quality.
Supervision
The role reports to the Senior Manager Design Control & Risk Management.