Job Description

Role: Software Quality Engineer

Remote

Duration: 9 Months

Software Quality Engineer (Medical Device Software)

Our client is seeking a highly skilled Software Quality Engineer to join their medical device software team. In this role, you will assist in the implementation of software for medical devices while ensuring compliance with quality, regulatory, and risk management standards. The ideal candidate will have hands-on experience with medical device software development and a strong understanding of relevant industry standards such as IEC 62304, 21 CFR Part 11, ISO 14971, and cyber security protocols. This role requires expertise in documentation, regulatory support, and risk management, alongside providing guidance on cyber security matters.

Key Responsibilities:

• Assist the medical device software team in implementing software solutions while ensuring adherence to quality, regulatory, and risk management standards.
• Provide quality and regulatory support to ensure compliance with industry-specific regulations throughout the software development lifecycle.
• Develop, review, and maintain applicable documentation, including Software Design Specifications (SDS), Software Requirement Specifications (SRS), Validation and Verification (V&V) Plans, and Test Protocols.
• Ensure compliance with relevant regulatory standards, including IEC 62304, 21 CFR Part 11, and ISO 14971, by conducting reviews and providing guidance during software development and testing phases.
• Work with cross-functional teams to identify and assess risks in software development, implementing risk management processes in line with ISO 14971.
• Provide guidance on cyber security best practices, ensuring that security controls are integrated into the software development process (no hands-on technical involvement).
• Collaborate with development teams to ensure effective implementation of requirements and to ensure regulatory compliance is met throughout the development cycle.
• Participate in audits and inspections related to software development processes and ensure corrective actions are implemented when necessary.
• Conduct internal reviews and audits of documentation and processes to ensure quality standards are met.
• Assist in preparing documentation for regulatory submissions, ensuring all documentation is compliant with applicable standards.

Required Skillset

• Proven Medical Device Software Experience
• Med Device Software Implementation Validation and Documentation
• IEC 62304, 21 CFR Part 11, ISO 14971

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