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Staff Software Quality Engineer at Telos Health Inc

Campbell, CA 95008, USA -

Full Time

Start Date

Immediate

Expiry Date

15 Aug, 25

Salary

177000.0

Posted On

15 May, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Devices, Validation, Test Protocols, Regulatory Requirements, Software Documentation, Management System, Software Development, Change Orders, Engineering Support, Software Verification

Industry

Information Technology/IT

Description

Responsibilities

Implement and maintain Quality Management System (QMS) processes, procedures, and techniques applicable to software development, verification, and validation.
Provide quality engineering support throughout all phases of the software development lifecycle, including requirements development, design reviews, risk management, V&V, and design transfer.
Create, review, and approve software documentation to ensure compliance with internal processes and external standards (e.g., IEC 62304).
Actively participate in the software risk management process, ensuring risks are appropriately identified, analysed, mitigated, and documented.
Review software verification and validation (V&V) deliverables, including test protocols, test reports, and traceability matrices, ensuring they meet regulatory and internal quality standards.
Review cybersecurity documentation, including threat assessments, vulnerability analyses, and mitigation plans, to confirm compliance with applicable standards such as FDA guidance on cybersecurity for medical devices.
Prepare and maintain the software design history file (DHF) in alignment with FDA and international regulatory requirements.
Perform document control activities related to software deliverables, ensuring accurate versioning and proper traceability.
Review design change orders (DCOs) involving software changes to ensure compliance with QMS and regulatory requirements.
Collect and report software quality metrics to monitor performance and identify opportunities for improvement.
Support projects with a sense of urgency consistent with corporate objectives.
May provide quality metric data to various functional groups within the organization