Senior Software Quality Engineer - Medical Device

• Location Marlborough, MA,Marlborough, MA, 01752,United States
• Employee Type Contractor or FT Employee
• Required Degree 4 Year Degree

ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges, and we take pride in providing them with transformative solutions with distinctive, sustainable and long-term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects.

Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

Develops, 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.

• 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.

• 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…