Senior QA Engineer: Regulated SDLC & Test Automation Lead

Rigaku Americas Corp.; Wilmington (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

Disability insurance

Job summary

Rigaku Americas Corp. in Wilmington, MA is seeking a Senior Software Quality Assurance Engineer to lead QA activities across the SDLC for new product development initiatives. The role ensures compliance with quality standards, regulatory requirements, and internal procedures.

The position interfaces with senior management and cross-functional teams, focusing on design control, risk management, verification, validation, and test automation to reduce cycle times while maintaining product quality.

Qualifications

• Bachelor's degree in Software Engineering, Computer Science, or a related technical field.
• Minimum of 5 years of experience in software quality engineering or regulated product development.
• Demonstrated experience leading design control, risk management, verification, and validation activities.
• Familiarity with software configuration management and collaboration tools, including Jira, Zephyr, and Confluence.
• Excellent written and verbal communication skills.

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.
• 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—SRS, SDP, Software Architecture Documents, and V&V Plans—comply with established SDLC procedures.
• Participate in Issue Review Team meetings to ensure defects and quality issues are evaluated, prioritized, and resolved.
• Support 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 quality system standards, regulations, and internal procedures.

Skills

Software quality engineering

Communication skills

Independent work

Education

Bachelor's degree in Software Engineering or Computer Science

Tools

Jira

Zephyr

Confluence

Job description

Rigaku Americas Corp. in Wilmington, MA is seeking a Senior Software Quality Assurance Engineer to lead QA activities across the SDLC for new product development initiatives. The role ensures compliance with quality standards, regulatory requirements, and internal procedures.

The position interfaces with senior management and cross-functional teams, focusing on design control, risk management, verification, validation, and test automation to reduce cycle times while maintaining product quality.