Director of Software Quality Assurance

Job Title: Director of Software Quality Assurance

Location: Remote

Employment Type: Full-time

About BigRio:

BigRio is a Digital Transformation consulting firm headquartered in Boston, MA, specializing in data and analytics, custom development, software implementation, data analytics, and machine learning/AI integrations. As a one-stop shop, we deliver cutting-edge and cost-conscious software solutions to clients across various industries. With diverse industry exposure, our teams of data architects, engineers, developers, and consultants tackle complex software and data challenges, providing best-in-class solutions.

Summary:

We are seeking a Director of Software Quality Assurance (QA) to lead the development and implementation of QA policies and procedures across software systems and bioinformatics analysis pipelines. This role will collaborate closely with cross-functional teams—including product managers, software engineers, scientists, and clinical reviewers—to ensure the adoption of QA best practices throughout the organization. The position is also responsible for maintaining compliance with regulatory standards, including CLIA, CAP, HIPAA, and FDA guidelines. This role is integral to ensuring the delivery of high-quality healthcare and analytical software products that have a positive impact on patients worldwide.

Responsibilities:

Implementation of QA Best Practices:

• Establish and enforce QA processes aligned with industry best practices, particularly within regulated healthcare environments.
• Lead the implementation of automated QA workflows integrated with CI/CD pipelines in an agile development setting.
• Maintain high standards in software testing through automated build, integration, regression, and end-to-end testing processes.

QA Systems Design:

• Design scalable QA processes and workflows for testing full-stack software applications across various platforms.
• Manage the development of automated QA systems for testing bioinformatics pipelines, particularly in Linux-based environments.
• Define and document software testing protocols and clinical validation procedures.

Strategic Leadership:

• Collaborate with internal and external stakeholders to develop QA strategies that support product goals and business needs.
• Provide leadership and mentorship to QA teams across a diverse portfolio of software and analytics solutions.
• Oversee the creation and implementation of training programs to ensure ongoing excellence in QA practices.

Regulatory Compliance:

• Ensure all software and analytical products comply with relevant regulatory requirements, including CAP, CLIA, HIPAA, and FDA standards.
• Lead the testing and validation of bioinformatics pipelines to ensure analytical accuracy, sensitivity, and specificity.
• Partner with quality management and compliance teams to audit and improve QA processes in alignment with regulatory guidelines.

Qualifications:

Skills:

• Strong expertise in QA methodologies and best practices.
• Proficient in industry-standard QA tools and automation frameworks.
• Excellent verbal and written communication skills.
• Familiarity with bioinformatics software and next-generation sequencing workflows is a plus.
• Experience with Jira, Confluence, and Agile methodologies is advantageous.

Education:

• Bachelor’s degree or higher in Computer Science, Bioinformatics, or a related field.

Experience:

• Minimum of 8 years in quality assurance roles.
• At least 5 years in a QA leadership capacity.
• Prior experience working in regulated healthcare or life sciences environments.

Equal Opportunity Statement:

BigRio is an equal-opportunity employer committed to creating a diverse and inclusive workplace. We value and promote diversity and prohibit discrimination based on various factors outlined by federal, state, or local laws. All qualified applicants will receive equal consideration for employment.