Collabera · 1 day ago
Quality Assurance Specialist II
Collabera is seeking a Quality Assurance Specialist II to support software quality and compliance activities within a regulated environment. This role focuses on reviewing, approving, and maintaining software lifecycle deliverables to ensure compliance with operating procedures and regulatory requirements while collaborating with cross-functional project teams.
Responsibilities
Maintain, configure, and implement data within a market authorization control system
Review and approve software lifecycle deliverables for compliance with operating procedures and regulatory requirements, including Title 21 Code of Federal Regulations Part Eleven
Participate in software reviews, risk assessments, and quality assurance activities supporting validated systems
Support planning, preparation, review, and approval of quality and validation documentation
Create and maintain quality system documentation using approved templates and guidelines
Assist with configuration and restriction implementation within enterprise resource planning systems
Collect, compile, and analyze quality metrics to support management reporting
Perform compliance assessments to identify gaps and recommend quality system improvements
Collaborate with cross-functional teams to resolve issues and support project objectives
Manage multiple tasks effectively while maintaining accuracy and attention to detail
Qualification
Required
Bachelor's degree in engineering, software quality assurance, computer science, or a related technical or scientific field, or equivalent experience
Four to seven years of experience in software quality assurance or software lifecycle activities within a regulated environment
Experience with enterprise resource planning systems, including SAP S Four Hana
Experience working with quality management systems and document management systems
Knowledge of software lifecycle processes, validation, and computerized system testing
Strong written and verbal communication skills with the ability to work collaboratively
Preferred
Experience with TrackWise or similar quality management platforms
Experience with change management modules and system configuration activities
Familiarity with IEEE, ISO, and Software Engineering Institute standards
Hands-on experience supporting software implementation and validation activities
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking or public transportation
Paid time off
Paid sick and safe time
Hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
H1B Sponsorship
Collabera 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 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Recent News
2024-04-09
2023-01-20
2022-04-19
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