Job Summary:
The Quality Assurance Specialist II will support software quality and compliance activities within a regulated healthcare environment.

This role focuses on reviewing and approving software lifecycle deliverables, supporting system validation, and ensuring compliance with regulatory and internal quality standards.

The position partners closely with cross-functional project teams to maintain high-quality documentation, system configurations, and audit readiness.

Key Responsibilities:

Review and approve software lifecycle deliverables to ensure compliance with regulatory and internal quality standards
Support computer system validation and testing activities in accordance with applicable regulations
Maintain, configure, and implement data within enterprise quality and authorization control systems
Participate in risk assessments, system reviews, and quality assurance evaluations
Create, review, and manage quality system documentation using approved templates and guidelines
Collect, compile, and analyze key quality metrics to support continuous improvement
Assist with configuration and restriction implementation within enterprise resource planning systems
Perform compliance assessments and identify gaps within quality processes
Collaborate with project teams to support planning, documentation, and approval activities

Required Qualifications:

Bachelor's degree in Engineering, Software Engineering, Life Sciences, or a related technical or scientific field
Four to seven years of experience in software quality assurance or computer system validation in a regulated environment
Hands-on experience with software lifecycle documentation and validation deliverables
Experience working with quality management systems and document management systems
Strong knowledge of regulatory requirements including Title Twenty One Code of Federal Regulations Part Eleven
Experience with enterprise systems such as SAP S Four HANA
Excellent written and verbal communication skills
Strong analytical, organizational, and time management skills

Preferred Qualifications:

Experience with TrackWise quality systems
Experience with change management modules within quality management systems
Understanding of computerized system testing and system configuration activities

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range:
$30/hr to $32/hr

Collabera

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