Quality Engineer

Authoring and maintaining validation documentation, including User Requirements Specification (URS), Functional and Design Specifications (FS/DS), Risk assessments, Requirements Traceability Matrix (RTM), Test Scripts (IQ/OQ/PQ), and Test Summary Reports. JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management.

Quality Engineer
Location: Cary, Illinois (Remote CST)
About Our Client:
Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefront—offering driven individuals the opportunity to make a meaningful impact every day.
Key Responsibilities:

• Partnering with Business Analysts to conduct requirements elicitation sessions with business stakeholders.
• Translating business needs into clear, testable functional requirements, user stories, and system requirements.
• Ensuring alignment between requirements, system specifications, and PLM configuration.
• Supporting user readiness and change activities by identifying deltas between current and future state processes.
• Collaborating with System Administrators to support configuration of PLM workflows, data mapping, roles, permissions, and supporting objects under guidance from system architects.
• Supporting functional prototypes, system demonstrations, and iterative configuration reviews.
• Participating in configuration review sessions to help identify validation impacts and support readiness for testing activities.
• Working closely with technical and integration teams to ensure PLM configuration aligns with overall system architecture and data models.
• Developing functional test scripts to support UAT and system validation cycles.
• Supporting UAT planning, readiness activities, and execution.
• Assisting business testers with issue resolution, defect logging, and evidence collection.
• Tracking defects, retesting, and resolution through closure.
• Validating that system functionality meets defined requirements and supports intended use.
• Authoring and maintaining validation documentation, including User Requirements Specification (URS), Functional and Design Specifications (FS/DS), Risk assessments, Requirements Traceability Matrix (RTM), Test Scripts (IQ/OQ/PQ), and Test Summary Reports.
• Ensuring validation deliverables comply with internal QMS requirements, GxP standards, and regulatory requirements.
• Working closely with IT, Quality, and project teams to support a smooth and compliant PLM implementation.
• Partnering with Quality and Validation teams to address findings, resolve gaps, and support audit readiness.
• Developing and maintaining system documentation such as process maps, work instructions, and job aids.
• Supporting validation of system integrations, workflows, permissions, and configuration changes.
• Providing functional input to develop training materials and user guides in collaboration with the Training Lead.

Qualifications:

• Bachelor’s degree in Computer Science, Engineering, Business, or a related field.
• Minimum of 3+ years experience in Computerized Systems Validation (CSV/CSA), with a strong focus on documentation.
• Proven hands-on experience in CSV/CSA execution within regulated environments.
• Skilled in authoring test scripts, protocols, and traceability documentation aligned with GxP/FDA standards.
• Deep understanding of requirements gathering, functional analysis, and system configuration.
• Knowledge of PLM software (e.g., Agile, MasterControl) and validation practices.
• Experience supporting QMS, document management, and vendor coordination during software projects.
• Familiarity with UAT planning, defect management, and validation tools.
• Strong organizational, analytical, and risk assessment skills.
• Excellent written communication and ability to work independently under tight deadlines.
• Experience working in cGMP, cGDP, and 21 CFR part 11 regulated environments.
• Prior involvement with healthcare product validation and regulatory audits.
• Knowledge of validation documentation standards, validation risk assessments, and system integrations.
• Hands-on experience with vendor management in software implementation projects.
• NO C2C CANDIDATES

Interested Candidates please apply on our website at https://jobs.jblresources.com.
For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com.
JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resources, logistics, operations, and supply chain management. As specialists in both permanent placement and contract services, our mission is to help companies and individuals become all they were created to be.
**JBL is an Equal Opportunity Employer and E-Verify Company