Senior Software QA Engineer - Lead Regulated SDLC Quality

Rigaku; Virginia (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) plan

Disability insurance

Job summary

Rigaku Analytical Devices in Wilmington, MA, is seeking a Senior Software Quality Assurance Engineer to lead QA and quality engineering across the SDLC for new product development initiatives. You will ensure processes meet quality standards, regulatory requirements, and internal procedures.

The role interfaces with Senior Management, Operations, Service, Product Development, Engineering, and external partners to communicate quality requirements, optimize development, and resolve conflicts.

Qualifications

• 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 Jira, Zephyr, and Confluence.

Responsibilities

• Serve as the software quality representative on project core and extended teams, ensuring compliance with design control throughout the product development lifecycle.
• Lead and support design control activities, including design planning, requirements management, design reviews, verification, validation, and test method validation.
• Drive continuous improvement to streamline verification and validation through risk-based approaches, process optimization, and test automation.
• Review and approve design, development, and product documentation.
• Drive product safety and risk management activities, including risk management plans and documentation.
• Ensure software deliverables (SRS, SDP, Software Architecture Documents, V&V Plans) comply with lifecycle procedures.
• Participate in Issue Review Team meetings to evaluate and resolve defects and quality issues.
• Support product transfer to manufacturing through review of process validation, design transfer, quality plans, and supplier documentation.
• Plan, conduct, and report internal audits against quality system standards, regulations, and internal procedures.

Skills

Software quality assurance

Quality engineering

Design control

Risk management

SQA leadership

Education

Bachelor's degree in Software Engineering or Computer Science

Tools

Jira

Zephyr

Confluence

Job description

Rigaku Analytical Devices in Wilmington, MA, is seeking a Senior Software Quality Assurance Engineer to lead QA and quality engineering across the SDLC for new product development initiatives. You will ensure processes meet quality standards, regulatory requirements, and internal procedures.

The role interfaces with Senior Management, Operations, Service, Product Development, Engineering, and external partners to communicate quality requirements, optimize development, and resolve conflicts.