Remote QA & Validation Analyst for FDA-regulated Software

Rangam; North Chicago (IL); Hybrid; USD 80,000 - 100,000; Full time

Benefits offered by this job

Flexible work schedule

Collaborative team environment

Job summary

An established technology company in Illinois is looking for a Software Quality Assurance Specialist. The role involves managing software lifecycle deliverables, ensuring compliance with FDA regulations and quality management systems. Candidates should have a Bachelor's degree in a related field and 4-7 years of relevant experience. The position offers a hybrid work model with three days on-site and two days remote, working Monday to Friday for eight hours each day.

Qualifications

• 4-7 years of experience in quality management systems or software engineering.
• Knowledge of FDA requirements and regulations, including 21 CFR Part 11.
• Experience in a regulated environment and familiarity with quality assurance activities.

Responsibilities

• Perform assessments for compliance with processes and regulations.
• Create and review project deliverables ensuring quality and compliance.
• Support project teams in planning and preparing quality documents.

Skills

Software lifecycle deliverables

Effective time management

Interpersonal skills

Analytical and troubleshooting skills

Education

Bachelor’s degree in Engineering or related field

Tools

SAP S4/HANA

TrackWise

Document management system

Job description

An established technology company in Illinois is looking for a Software Quality Assurance Specialist. The role involves managing software lifecycle deliverables, ensuring compliance with FDA regulations and quality management systems. Candidates should have a Bachelor's degree in a related field and 4-7 years of relevant experience. The position offers a hybrid work model with three days on-site and two days remote, working Monday to Friday for eight hours each day.