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
