Senior Software Quality Engineer — Validation & Compliance

Theuniversityunion; Marlborough (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

ECI is seeking an experienced software quality professional to develop, validate, and maintain standards for software quality methods, processes and procedures ensuring compliance with internal and external regulatory requirements.

The role includes coaching team members, guiding validation strategies, and leading enterprise system verification and validation activities across Waterfall and Agile environments.

Qualifications

• Bachelor's degree (or higher) in Engineering or related field.
• 8+ years of related experience, including 3+ years in Software Quality and validation.
• Knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices.
• 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.

Responsibilities

• Acts as an effective 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/ coach/ train project teams on effective and efficient implementation of software validation processes.
• Demonstrate mastery of the software validation processes
• Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements.
• Works with management to understand priorities and plans/provides input to resource and time allocation accordingly.
• Plays key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement a validation strategy to ensure compliance.
• Guides implementation of enterprise systems solutions through planning, system integration, and verification and validation activities.
• Proactive involvement in continuous improvement activities while ensuring software systems are defensible for regulatory requirements.
• Contributes to the development, review and / or approve of SOPs and supporting Work Instructions.
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Software verification and validation activities.
• Communicates the value of the Software Quality process or cross-functional software validation initiatives. Ensures buy-in from project team members to the disciplines, decisions, and practices of the Software-Validation.
• Provides structured Quality Assurance activities and metrics to promote efficient and cost-effective operations.

Skills

Agile methodologies

Software quality

Communication skills

Regulatory knowledge

Education

Bachelor's degree in Engineering or related fields

Tools

JIRA

Xray

qTest

Job description

ECI is seeking an experienced software quality professional to develop, validate, and maintain standards for software quality methods, processes and procedures ensuring compliance with internal and external regulatory requirements.

The role includes coaching team members, guiding validation strategies, and leading enterprise system verification and validation activities across Waterfall and Agile environments.