Software Quality Engineer
Vor 7 Tagen
At ONWARD we're looking for a Software Quality Engineer to join our team.
About the jobAs a Software Quality Engineer, you will be instrumental in ensuring the production and delivery of innovative therapies for individuals with spinal cord injuries. Your primary focus will be on upholding the highest standards of quality and compliance in the development of ONWARD medical systems. These include Class III medical systems, which encompass both implantable and external medical device components, as well as Software as a Medical Device (SaMD). You will take the lead in establishing and implementing compliant Quality Assurance processes that oversee the design, development, validation, and clinical application of these advanced medical systems.
Responsibilities
- Serve as the Quality representative for the Design Control process in Software development, ensuring consistent application and maintenance.
- Provide expert quality support for Software design and development, including safety classification, risk assessment, testing, verification, validation, configuration management, and software releases.
- Maintain a compliant Bug Tracking System, supporting anomaly management, problem resolution, and evaluations while ensuring effective follow-up.
- Guide Software Teams in adhering to industry standards and regulatory guidelines, offering essential training to enhance compliance awareness.
- Oversee the implementation, maintenance, and continuous improvement of ONWARD's Software lifecycle processes, ensuring alignment with evolving industry standards and regulatory requirements.
- Manage Software supplier quality, including supplier certifications and audits, to maintain high compliance standards.
- Support regulatory compliance efforts related to Software, Cybersecurity, usability, and human factors in accordance with IEC 62366-1 and other relevant standards for Active Implantable Devices and Software as Medical Devices.
- Act as the Quality representative for overall Design Control, covering Hardware and System Design Reviews, Design Verification, and Design Validation.
- Oversee Change Control and Problem Resolution processes, including Non-Conformities, Device Deficiencies, and CAPA (Corrective and Preventive Actions).
- Lead structural improvements in the Quality Management System (QMS) to enhance efficiency and compliance.
- Drive continuous improvement in Quality System processes, fostering a culture of excellence, compliance, and innovation.
- Master's degree in Life Sciences, Engineering, or a related field.
- 3 to 5 years of relevant industry experience in medical devices, preferably Class III (MDR) or Active Implantable Medical Devices (AIMD).
- Expertise in FDA software validation, Cybersecurity, and IEC 62304 Software Lifecycle process standards.
- Strong knowledge of ISO 14971 (Risk Management for Medical Devices).
- Experience applying usability engineering principles in accordance with IEC 62366-1.
- 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.
- Programming experience with one or more languages: Embedded C, C++, Kotlin, Java, and Python.
- Familiarity with Jama and Jira is a plus.
- Detail-oriented with a strong drive for precision and consistency.
- High integrity and commitment to quality.
- Results-driven, hands-on professional who thrives in a fast-paced, international, and cross-functional environment.
- Fluency in English; proficiency in French and/or Dutch is highly appreciated.
- Represents the ONWARD Code.
Supervision
Individual contributor reporting to the Senior Manager Design Control & Risk Management.
Apply for the jobDo you want to join our team as our new Software Quality Engineer? Then we'd love to hear about you
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