Software Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the creation, execution, and upkeep of software-specific Quality Management System (QMS) processes, including Software Development Life Cycle (SDLC), Software Risk Management, and Cybersecurity.

• Act as the Quality representative within software development and bioinformatics teams.

• Offer Quality review, guidance, and process support for software engineering tasks and technical documentation.

• Carry out designated software development Quality tasks and aid in the development of the SDLC QMS process.

• Supervise software design control activities, encompassing requirements, architecture documentation, code review records, and verification and validation documentation.

• Engage in the Design and Development File documentation throughout the product lifecycle.

• Direct and assess software risk management activities.

• Assist in the validation of non-product software tools.

• Examine and address software-related nonconformances, deviations, and Corrective and Preventive Actions (CAPAs).

• Provide Quality input concerning cybersecurity design control, risk management, vulnerability management, and post-market activities.

• Facilitate internal and external audits by preparing software-related objective evidence and aiding in the resolution of findings.

• Keep abreast of regulatory expectations, standards, and best practices for software in In Vitro Diagnostics (IVDs), suggesting updates to processes and documentation.

• Contribute to ongoing improvement initiatives associated with software development and quality processes.

⛳️ Requirements

• A bachelor's or advanced degree in a pertinent scientific or technical field (e.g., Computer Science, Engineering, Bioinformatics).

• Over 6 years of experience in software Quality Assurance (QA).

• More than 4 years of experience in medical device or FDA-regulated software development.

• Hands-on experience with design controls, ISO 13485, ISO 14971, and IEC 62304 regulations.

• Experience with Software as a Medical Device or medical devices that include software.

• Strong comprehension of design control procedures and the software development lifecycle within regulated environments.

• Experience in supporting regulatory submissions and audits.

• Capability to manage various projects and priorities in a dynamic environment.

• Certification as a Software Quality Engineer (CSQE) is preferred.

🏝️ Benefits

• Competitive compensation and benefits that align with local market practices and legal obligations.

• Fully remote work from a home office or another appropriate remote location.

• Standard work hours from Monday to Friday, 9 AM to 5 PM EST.