Bachelor's degree in Engineering or related fields
8+ years of experience in Software Quality and validation
3+ years in software validation specifically
Familiarity with 21 CFR 820, ISO 13485, and CFR Part 11
Experience with Agile methodologies
Knowledge of work management tools like JIRA and qTest
Experience with AI applications
Responsibilities
Develop and maintain software quality standards and procedures
Provide independent review and guidance on software deliverables
Coach and train project teams on software validation processes
Lead the development and implementation of validation strategies
Guide enterprise systems solutions through integration and validation
Contribute to the creation and approval of SOPs and Work Instructions
Communicate the value of Software Quality processes across the organization
Benefits
Opportunities for professional development and training
Collaborative work environment
Involvement in innovative projects
Access to cutting-edge technology
Support for continuous improvement initiatives
Full Job Description
Description
About the RoleDevelops, modifies, applies, and maintains standards for software quality methods, processes and procedures to meet internal and external regulatory requirements. Provides expertise and conducts evaluation of software systems validation activities including requirements, design, development, integration, test, verification, and implementation. Establishes methods for monitoring the compliance of software system processes, standards, and procedures. Coaches less experienced colleagues and executes on projects along with other members of the team. Role includes AI/IT/clinical/manufacturing/Quality software and computerized system validation and maintenance. Role requires expertise in software validation as it applies to both Waterfall and an Agile environment.
What You'll Do
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.
What We Look For
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.
Strong written and verbal communication skills
Creative and innovative thinking skills
Experience managing projects and project deliverables to completion.
Comfortable working independently and as part of a cross-functional team
Ability to manage multiple priorities and work without ambiguity.
