Software Quality Engineer

Responsibilities

Serve as key Quality point of contact for maintaining internal software, system, and process compliance; Support the development or maintenance of software supply chain risk management processes supporting software supply chain cybersecurity, security patch development, deployment, and secure software configuration management; Execute activities as per documented QMS Quality Plan by supporting product security process updates, inclusive of but not limited to, vulnerability management, threat modelling, patch management and metrics, and other product related cybersecurity documentation; Provide support actively and directly interacting with inspectors/auditors during on-site Audits, obtaining required information, and assisting with corrective action and/or remediation plans; Contribute directly to the completion of projects through the management of assigned contract personnel, review of protocols (IQ/OQ/PQ), documents, reports, and data tables generated by peers and contract personnel; Co-ordinate and execute training of required personnel on the internal systems, procedures, and methodologies; Participate in cross-functional project teams including development & deployment teams as well as Manufacturing, Engineering, Quality, and other groups; Support activities that include but are not limited to document review and approval Including assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols (IO/OQ/PQ), traceability matrix, error reports/defect report forms and summary reports; Conduct timely validation of security patches in the system and ensure data integrity in the process and system; Responsible for translating and implementing new and updated product security QMS requirements into local business standard operating procedures, work instructions, and templates; Review and analyze validation data and make recommendations for changes and/or improvements by providing guidance on performing validation of computer software and systems; Recognize opportunities for efficient process integration of related MedTech product security process updates into local QMS and technical device documentation; Work in an advanced technical and regulated environment of medical devices, data, and data systems throughout a defined and documented product lifecycle in accordance with EUMDR, and FDA cybersecurity guidelines; Execute privacy and data lifecycle process documentation updates.

Requirements

Bachelor's degree or equivalent in Computer Science or equivalent in a related field or a foreign equivalent; relevant experience