Sr. Software Quality Assurance Engineer

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DIVISION: Rigaku Analytical Devices, Wilmington, MA

POSITION: Senior Software Quality Assurance Engineer (onsite)

REPORTS TO: Software Manager

Job Description:

Rigaku is seeking a Senior Software Quality Assurance Engineer to lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle (SDLC) for new product development initiatives. This role is responsible for ensuring that software development processes comply with applicable quality standards, regulatory requirements, and internal procedures.

The position interfaces with Senior Management, Operations, Service, Product Development, Engineering, and external partners on issues related to product development, released-product support, and software used to automate quality system processes. The ability to effectively communicate software quality and design-control requirements, optimize development processes, and resolve ambiguous or conflicting requirements is critical to success in this role.

Responsibilities:

• Serve as the software quality representative on project core and extended teams, ensuring compliance with design control requirements throughout the product development lifecycle.
• Lead and support design control activities, including design planning, requirements management, design reviews, verification, validation, and test method validation.
• Lead continuous improvement efforts to streamline software verification and validation activities through risk-based approaches, process optimization, and test automation, reducing cycle times while maintaining product quality and regulatory compliance.
• Review and approve design, development, and product documentation.
• Drive product safety and risk management activities, including authoring and maintaining risk management plans and associated documentation.
• Ensure software deliverables-including Software Requirements Specifications (SRS), Software Development Plans (SDP), Software Architecture Documents, and Software Verification and Validation (V&V) Plans-comply with established software development lifecycle procedures.
• Participate in Issue Review Team meetings to ensure software defects and quality issues are appropriately evaluated, prioritized, and resolved.
• Support successful product transfer to manufacturing through review of process validation activities, design transfer documentation, quality plans, and supplier documentation.
• Plan, conduct, and report internal audits against applicable quality system standards, regulations, and internal procedures.

Requirements:

• Bachelor's degree in Software Engineering, Computer Science, or a related technical field.
• Minimum of 5 years of experience in software quality engineering, quality assurance, or regulated product development.
• Demonstrated experience leading design control, risk management, verification, and validation activities.
• Strong familiarity with software configuration management, source control systems, and collaboration tools, including Atlassian Jira, Zephyr, and Confluence.
• Excellent written and verbal communication skills.
• Self-motivated, detail-oriented, and capable of working independently with minimal supervision.

Preferred Qualifications:

• GUI design principles for portable instrumentation and the application of Human Factors Engineering (HFE) methodologies.
• Embedded Linux systems, including familiarity with Linux kernel architecture and kernel module development concepts.
• Modern web application architectures and technologies, including PHP, JavaScript, and React.
• Database architecture, performance optimization, and networking fundamentals.
• Scripting for test automation and development support using Bash, PowerShell, or similar scripting languages.
• Software test automation concepts, including automated functional, integration, regression, and system-level testing.
• Experience supporting software development and quality engineering tools, including source control systems, defect tracking systems, test management platforms, and CI/CD environments.
• Experience with test automation frameworks and tools such as Selenium, or equivalent technologies used for desktop, web, or embedded software validation.
• Ability to evaluate software architectures, requirements, and technical deliverables across multiple software disciplines.
• Demonstrated success leading quality activities for complex technology development projects involving cross-functional teams.
• Familiarity with automated verification and validation approaches for scientific, analytical, or embedded instrumentation software, including hardware-software integration testing and test framework development.

Rigaku offers a rewarding work environment and excellent benefits. All applicants are kept in strict confidence. Our benefits package includes medical, dental, and vision coverage; short- and long-term disability insurance; life insurance; Section 125 flexible spending accounts; a 401(k) plan; and more.

Rigaku is an EEO/AA Employer Disabled/Veteran.

Applicants must be authorized to work in the United States.

• Position not approved for relocation assistance*

All applicants should apply directly; agency applications or referrals will not be considered at this time