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Job #: R-00014092
Location: Baltimore, MD
Category: Testing and Quality Assurance
Schedule (FT/PT): Full time
Travel Required: No
Shift: Day
Potential for Telework: No
Clearance Required: Public Trust
Referral Eligibility: Ineligible
Group: Health

Job Description:

The Systems for Inspections, Recalls, Compliance Enforcement (SIRCE) and Imports program supports the Food and Drug Administration (FDA) Office of Regulatory Affairs' (ORA) critical work to safeguard the foods, drugs, devices, biologics, and veterinary products that the Agency regulates. These systems continue to evolve to meet emerging business needs and to support new mandates and initiatives. It is important to analyze and implement advances in technologies that will improve efficiency and performance leading to greater user satisfaction and reducing the cost of operations and maintenance (O&M). Effort is underway to develop state of the art applications that can be used on various platforms and to retire some of the legacy systems with modern and efficient applications.

Primary Responsibilities
- Work with FDA business owner in understanding the business needs and determining appropriate test scenarios to support demonstrating the capability
- Develop test cases and document exceptions based on FDA business and project needs and specific program requirements
- Collaborate with developers and business analysis in ensuring requirements are implemented correctly and meet customers' expectations
- Ability to identify solution and evaluate solution to complex system problems with mentoring and coaching from more senior team leaders
- Actively participate/lead in the discovery/validation/verification process throughout the development life cycle
- Actively engage/lead in process improvement initiatives

Basic Qualifications
- Basic knowledge with process modeling or data analytics
- Demonstrated understanding of full software development life cycle
- Willingness to learn new techniques such as, 508 testing requirements, regression testing, ability to learn quickly
- Demonstrated good understanding of engineering or math fields
- Excellent verbal and written communication skills, including experience working directly with team members to discuss requirements and objectives
BA/BS degree in CS, IT, Math or related field
- Ability to obtain and maintain a Public Trust security clearance
- US citizen or permanent resident

Preferred Qualifications
• Prior experience with HP ALM and JIRA
• Academic Experience in developing Job Flow, Business Process and Functional Flow diagrams
• Experience with the FDA customer or related customer experience (in a Health systems technology area)


Leidos is a Fortune 500® information technology, engineering, and science solutions and services leader working to solve the world's toughest challenges in the defense, intelligence, homeland security, civil, and health markets. The company's 32,000 employees support vital missions for government and commercial customers. Headquartered in Reston, Virginia, Leidos reported annual revenues of approximately $10.19 billion for the fiscal year ended December 28, 2018. For more information, visit .

Pay and benefits are fundamental to any career decision. That's why we craft compensation packages that reflect the importance of the work we do for our customers. Employment benefits include competitive compensation, Health and Wellness programs, Income Protection, Paid Leave and Retirement. More details are available here .

Leidos will never ask you to provide payment-related information at any part of the employment application process. And Leidos will communicate with you only through emails that are sent from a email address. If you receive an email purporting to be from Leidos that asks for payment-related information or any other personal information, please report the email to .

All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.

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