Senior Software Quality Engineer - Medical Device #0592

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

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

About ECI

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.

About the Role

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.

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.

ECI is an equal opportunity employer.

All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.