Mindlance · 20 hours ago
QA Specialist II
North Chicago, IL
Full-time
Hybrid
Mid Level
4+ years expMindlance is a company seeking a QA Specialist II to manage software quality assurance activities. The role involves ensuring compliance with FDA requirements and overseeing software lifecycle deliverables, while also supporting project teams in planning and quality documentation.
Human Resources
Responsibilities
Maintenance, Configuration and Implementation of data for *** Market Authorization control system
Knowledge or experience in requirements gathering, analysis techniques, software verification/validation techniques, configuration management techniques or documentation standards
SAP S4/HANA and TrackWise experience preferred
Good verbal and written communication skills. Knowledge or experience in computerize system validation/testing
The candidate is responsible for all software quality assurance activities such as evaluation of software lifecycle (SLC) deliverables for compliance with Operating Procedures, FDA requirements and the CFR including 21 CFR Part 11
Lead or participate in various reviews, risk analyses and other software quality assurance activities with primary focus on review and approval of restrictions, configurations, and validation supporting documents
Have a background in software engineering, software lifecycle activities, or software validation and be familiar with the work products that result from SLC key activities
The candidate should be familiar with IEEE, SEI, ISO and have experience in a regulated environment. Analytical and troubleshooting skills are important, as is the ability to manage tasks. Must be able to manage multiple tasks and resources
Support project teams in planning, preparation, reviewing and approval of quality documents. Create quality system documentation with guidance from technical teams following approved templates and guidelines
Collect and compile key quality metric data
Assist with processing configuration and restriction implementation within SAP S4/ HANA enterprise system
Ability to maintain a high degree of accuracy and analytical thinking
Works well with manager guidance to complete tactical objectives while able to manage own time effectively
Perform assessments to determine compliance to processes and regulations to identify potential gaps and suggest improvements within our quality system
Assist in the design of effective quality systems, procedures and/or processes to ensure compliance as well as efficiency throughout our quality system
Qualification
Required
SAP S4/Hana experience
Quality Management systems experience including Document management system
Minimum Bachelor's degree, background in software engineering or software quality assurance, Engineering or other technical/ scientific area or equivalent experience
4-7 YEARS EXPERIENCE
Experience working with software lifecycle deliverables and ability to incorporate updates to meet the needs of the business and project teams
Effective time management and ability to adjust workload to meet customer needs
Good interpersonal skills with the ability to work collaboratively with multiple project teams of differing backgrounds
Must be able to work 50 weeks out of the year, excluding holidays
Preferred
Quality Management System – Change Management module, and technical skills – implementation and configuration are preferred
Understanding of computerize system Testing
Hands-on professional with experience in the software lifecycle (SLC)
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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