Senior Software Quality Engineer – Regulatory Validation

ECI; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

ECI is seeking an experienced Software Quality and Validation professional in the life sciences space to develop, apply, and maintain standards for software quality methods. You will evaluate validation activities across requirements, design, development, integration, test, verification, and implementation in Waterfall and Agile environments.

The role requires coaching colleagues, guiding validation strategies, and ensuring regulatory compliance for FDA/ISO standards within a collaborative team.

Qualifications

• Bachelor's degree (or higher) in Engineering or related fields
• 8+ years of related experience, including 3+ years’ experience in Software Quality and validation
• Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices
• Must have good understanding of quality system requirements and how each quality system element connects
• Some experience in working with Agile software development and validation methodologies
• Some experience/knowledge of work management and testing tools (such as JIRA, Xray, qTest)
• Some experience of AI applications
• Experience working with a diverse population of internal and external customers
• Comfortable speaking and presenting to leadership

Responsibilities

• Acts as a team member providing independent review and guidance on deliverables used to develop, implement and maintain AI/IT/clinical/manufacturing/quality software.
• Acts as a subject matter expert on software validation to guide teams on implementation of software validation processes.
• Demonstrate mastery of the software validation processes.
• Understand quality philosophies, principles, methods, tools, standards, and regulatory requirements.
• Collaborate with management to understand priorities and allocate resources/time.
• Lead and direct validation deliverables and strategy to ensure compliance.
• Guide enterprise system solutions through planning, integration, verification and validation activities.
• Involve in continuous improvement while ensuring software systems are defensible for regulatory requirements.
• Contribute to SOPs and supporting work instructions.
• Communicate software verification and validation concepts to all levels of the organization.
• Promote value of Software Quality processes and cross-functional validation initiatives.
• Provide structured QA activities and metrics to support efficient operations.

Skills

Software quality

Software validation

Agile methodologies

JIRA

Xray

qTest

AI applications

Regulatory compliance

Team leadership

Education

Bachelor's degree in Engineering or related field

Tools

JIRA

Xray

qTest

Job description

ECI is seeking an experienced Software Quality and Validation professional in the life sciences space to develop, apply, and maintain standards for software quality methods. You will evaluate validation activities across requirements, design, development, integration, test, verification, and implementation in Waterfall and Agile environments.

The role requires coaching colleagues, guiding validation strategies, and ensuring regulatory compliance for FDA/ISO standards within a collaborative team.