Engr 2 Software Quality

KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

SUPPLIER CALL:

FRIDAY, MARCH 28TH
2:30PM EST

Dial in by phone
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Work days/hours: M - F 8am - 5pm

Max bill rate: /hr

If local to Durham, works onsite Mon - Thurs, remote on Fridays

Can be fully remote. Would need to travel to Client for one week a month (Client covers travel cost)

If fully remote, please list candidates city and state on the top of the resume.

We are seeking an experienced Software Quality Engineer to develop and implement Quality Management System (QMS) design controls for pharmacy automation projects, manage design control documentation, and ensure compliance with industry standards. The role involves configuring, maintaining, and supporting Atlassian tools (Jira, Confluence, etc.), optimizing workflows, and integrating with other tools. The candidate will drive change management, perform system validation, develop automation, guide data migrations, and create training materials. Collaboration with cross-functional teams and staying updated with industry best practices are essential.

Responsibilities

• Assist in the development and implementation of QMS design controls for pharmacy automation projects.

• Assist in creation and maintenance of design control documentation management utilizing tools like confluence, including importing and managing templates.

• Collaborate with cross-functional teams, including R&D, quality, and regulatory, to ensure compliance with industry standards and regulations.

• Support management of design control documentation, such as design plans, risk management files, and verification and validation protocols.

• Participate in design reviews and provide input on design control processes and documentation.

• Conduct research and stay up-to-date with industry best practices and regulatory requirements related to QMS and design controls.

• Assist in the preparation of reports and presentations for internal stakeholders and leadership

• Atlassian Administration: Configure, maintain, and support Jira, Confluence, Jira Service Management, and integrations with other tools (e.g. Aha.). Ensure tools are optimized for organization workflows, reporting needs, processes, and performance.

• Own and drive change management process

• Evaluate change requests according to impact, maintainability, regulatory requirements, and GxP validation requirements

• Perform system validation, as necessary for compliance

• Integrations: Implement and manage integrations between Jira and other tools (e.g., Confluence, Aha., Microsoft Teams, Github, Salesforce, etc.) to streamline development and collaboration workflows.

• Automation: Develop and maintain automation across the tooling ecosystem to streamline workflows and increase efficiency.

• Guide teams through data migrations and onboarding

• Maintain detailed documentation of configuration changes, best practices, and training materials for end users.

• Create and deliver training
Skills and Competencies

• Deep knowledge of Quality Management Systems

• Able to perform all functions of Jira and Confluence cloud administration to ensure the production GxP system remains stable and available and to ensure no loss of data.

• Strong communication skills with ability to effectively deliver complex messages and teach new concepts

• Familiarity with Jira REST APIs and ability to implement custom scripts for enhanced functionality.

• Understanding of agile methodologies, SAFE, and their implementation in Jira.

• Excellent problem-solving skills and the ability to troubleshoot complex issues within the Atlassian cloud product suite.

Qualifications and Experience

• Bachelor's degree required. Computer Science, IT related field preferred. All fields considered with experience that aligns with posted responsibilities.

• 3-5 years of experience as a Software Quality Engineer

• 3-5 years of experience in Atlassian Cloud Tool Administration

• Atlassian certification is a plus (ACP-120 Jira Administration for Cloud Certification)

• Prior experience in integrating Jira with other business tools like Github, Aha., and Salesforce.

• Experience administering Aha. is preferred

• Experience migrating teams from Azure DevOps and Team Foundation Server (Our Client) to Jira is preferred

• Experience with software development in a regulated field is preferred

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at .

Benefits with Kaygen
Healthcare Insurance
Vision and Dental Insurance
401(k) Retirement Plan
Free Life Insurance
Vacation Time Off
Sick Time Off
Family Medical Leave (FMLA)
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