REMOTE Software Quality Assurance Engineer

This role serves as a core member of software and firmware product development teams, providing technical leadership in software quality assurance throughout the full product lifecycle. The engineer oversees risk management, design control compliance, development and verification of design requirements and architecture, and execution of verification and validation activities, including unit and integration testing. The position plays a key role in ensuring that software and firmware for medical and implantable devices meet regulatory, quality, and cybersecurity expectations, while also supporting validation of software used in manufacturing processes., * Serve as a core team member on software and firmware product development projects, providing technical leadership and direction on software quality assurance activities.

• Own and maintain the risk management file for assigned products, ensuring compliance with design control regulations and applicable standards throughout the product lifecycle.
• Develop and review design requirements, architecture specifications, and verification and validation plans, including unit and integration testing strategies.
• Chair the change control board within projects, leading the evaluation and approval of change requests and defects identified during development.
• Provide detailed and constructive technical feedback during code reviews to improve software and firmware quality and maintainability.
• Lead and oversee investigations of software and firmware-related complaints, defects identified during development, manufacturing nonconformities, audit findings, and CAPAs, ensuring timely identification of root cause and implementation of effective corrective actions.
• Generate, maintain, and update risk management documentation, ensuring it remains accurate, complete, and aligned with current product status and known risks.
• Lead the post-market cybersecurity process by monitoring potential threats, coordinating with security experts, and initiating further review and analysis as needed.
• Serve as a core team member for validation of software used in the manufacturing process, providing technical leadership and direction on validation activities.
• Ensure completeness and accuracy of change impact assessments for manufacturing and non-product software, and verify that validation activities comply with regulations and internal procedures.
• Assess change risk and ensure that acceptance criteria and validation evidence are sufficient to support continued compliant operation of software and firmware.
• Work with and manage suppliers during development, coordinating technical requirements and quality expectations to support overall program needs.
• Ensure compliance with software and firmware development procedures and non-product software validation procedures, including adherence to relevant standards such as IEC-related software requirements and testing expectations.
• Contribute to successful regulatory audits by coordinating back room and front room activities, or by serving as a subject matter expert in software quality, validation, and risk management.
• Collaborate closely with firmware and software teams to align on design, implementation, testing, and quality objectives for medical and implantable devices., The role operates in a collaborative environment, working closely with a team of more than 10 software quality professionals and interacting frequently with firmware and software development groups. The position offers a hybrid work arrangement, typically involving 2-3 days onsite and 2 days remote each week, with flexibility for onsite or fully remote collaboration depending on business needs. The environment emphasizes cross-functional teamwork, technical excellence, and adherence to regulatory and quality standards for medical and implantable device software., Operations Management Automation Kubernetes Observability OpenTelemetry Virtualization Microsoft Azure Windows PowerShell Business Valuation Root Cause Analysis Information Systems NetApp Applications Time Off Management Full Stack Development Unified Communications Artificial Intelligence Business Transformation SQL (Programming Language) Troubleshooting (Problem Solving) Application Performance Management +0 Avionics Test Engineer Actalent

Tustin, CA*Remote

Auditing Firmware Visionary Leadership Innovation Code Review Coordinating Investigation Change Control Cyber Security Risk Management Problem Solving Medical Devices Change Requests Computer Science Software Testing Quality Assurance Impact Assessment Quality Management Root Cause Analysis Integration Testing Supplier Management Software Validation Software Development Computer Engineering Technical Leadership Firmware Development Virtual Collaboration Electrical Engineering Technical Requirements New Product Development Manufacturing Processes Artificial Intelligence C (Programming Language) C# (Programming Language) Engineering Design Process Software Quality (SQA/SQC) Verification And Validation Software Product Management Product Lifecycle Management Cross-Functional Coordination Corrective And Preventive Action (CAPA), * Proven experience in software quality assurance for software and firmware products, preferably in highly regulated environments.

• Hands-on experience developing software or firmware in the medical device industry.
• Strong proficiency in C programming for embedded or firmware applications.
• Experience working with implantable device software or firmware.
• Demonstrated experience collaborating effectively with software and firmware teams on design, implementation, and verification activities.
• Knowledge of IEC-related software requirements and software testing standards applicable to medical devices.
• Experience with validation of software used in manufacturing processes, including change impact assessment and risk evaluation.
• Understanding of design control regulations and risk management principles for medical device software.
• Bachelor's degree (B.S.) in Computer Engineering, Computer Science, Electrical Engineering, or a closely related technical field.

Additional Skills & Qualifications

• Experience with C# in addition to C for software or tools development.
• Experience in software validation, including verification and validation planning, execution, and documentation.
• Familiarity with quality assurance methodologies and best practices for medical device software and firmware.
• Experience working with post-market processes, including complaint handling, nonconformity investigations, and CAPA management.
• Exposure to cybersecurity considerations for medical device software, including monitoring and responding to emerging threats.
• Experience interacting with regulatory auditors as a subject matter expert in software quality or validation.
• Strong analytical, problem-solving, and root cause analysis skills, particularly in complex embedded or firmware environments., Auditing Firmware Visionary Leadership Innovation Code Review Coordinating Investigation Change Control Cyber Security Risk Management Problem Solving Medical Devices Change Requests Computer Science Software Testing Quality Assurance Impact Assessment Quality Management Root Cause Analysis Integration Testing Supplier Management Software Validation Software Development Computer Engineering Technical Leadership Firmware Development Virtual Collaboration Electrical Engineering Technical Requirements New Product Development Manufacturing Processes Artificial Intelligence C (Programming Language) C# (Programming Language) Engineering Design Process Software Quality (SQA/SQC) Verification And Validation Software Product Management Product Lifecycle Management Cross-Functional Coordination Corrective And Preventive Action (CAPA) +0, LabVIEW Teamwork Avionics Scripting Visionary Innovation Traceability Test Planning Code Coverage Test Equipment Detail Oriented Test Automation Data Collection DO-160 Standard Test Engineering Procedure Development Artificial Intelligence Engineering Design Process Python (Programming Language) Continuous Improvement Process Troubleshooting (Problem Solving) Military Standards And Specifications

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