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Sr. TrackWise Consultant : 26-02120

Akraya, Inc.

Sunnyvale, CA

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JOB DETAILS
SALARY
$115–$120 Per Hour
SKILLS
Analysis Skills, Automation, Biology, Business Analysis, Business Processes, Change Control, Code of Federal Regulations, Consulting, Corrective and Preventative Action (CAPA) Systems, Crystal Reports, Customer/Client Research, Document Management, Documentation, FDA (Food and Drug Administration), Functional Testing, GxP, Healthcare Quality, Identify Issues, Java, Knowledge Management, Leadership, Maintain Compliance, Medical Equipment, Medical Organizations, Mentoring, Offshoring, Production Support, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulatory Compliance, Regulatory Requirements, Reporting Skills, Requirements Management, Requirements Validation/Verification, Root Cause Analysis, SAP, Software Administration, Software Development Lifecycle (SDLC), Software Validation, Systems Administration/Management, Systems Analysis, Technical Recruiting, Technical/Engineering Design, Validation Documentation, Web Programming, Web Services
LOCATION
Sunnyvale, CA
POSTED
1 day ago
Primary Skills: TrackWise Configuration (Expert), TrackWise Web Services (Expert), Crystal Reports Development (Expert), Java Development (Advanced), Quality Systems & Medical Device Compliance (Expert)
Contract Type: W2
Duration: 12 Months
Location: Sunnyvale, CA (Hybrid – Local Candidates Preferred)
Pay Range: $115 - $120/hour on W2

Job Summary:
We are seeking a Senior TrackWise Consultant to support the design, configuration, enhancement, and implementation of TrackWise Quality Management System (QMS) solutions for a leading medical device organization. The ideal candidate will have extensive experience with TrackWise configuration, workflow automation, web service development, Crystal Reports, and Java development, along with a strong understanding of regulated environments, CAPA, Complaints, and compliance standards such as FDA 21 CFR Part 11, GxP, and GAMP.
Key Responsibilities:
  • Analyze business requirements and design scalable TrackWise solutions to support Quality Management processes.
  • Configure TrackWise workflows, business rules, forms, notifications, automation, and system enhancements.
  • Develop and maintain TrackWise Web Services (OWS/IWS) including Search, Populate, and Transfer services.
  • Design, develop, and implement Crystal Reports for quality and compliance reporting.
  • Perform solution design, system configuration, functional testing, validation support, deployment, and production support.
  • Collaborate with business users to gather requirements and translate them into detailed functional specifications.
  • Troubleshoot application issues, perform root cause analysis, and implement system improvements.
  • Support software lifecycle management including upgrades, change control, documentation, and user training.
  • Partner with onsite and offshore teams to deliver high-quality, compliant software solutions.
  • Ensure adherence to SDLC processes, regulatory requirements, and quality system standards.
Must-have Skills:
  • 8+ years of hands-on TrackWise System Analysis and Configuration experience.
  • Strong expertise in TrackWise Configuration, workflows, business rules, TWC automation, and notifications.
  • Experience developing TrackWise Web Services (OWS/IWS) including Search, Populate, and Transfer services.
  • Strong experience developing Crystal Reports.
  • Solid Java programming experience.
  • Experience supporting CAPA, Complaints, Quality Management Systems (QMS), and regulated business processes.
  • Strong understanding of FDA 21 CFR Part 11, GxP, GAMP, and software validation requirements.
  • Experience gathering business requirements and preparing functional design documentation.
  • Familiarity with SDLC methodologies, testing, deployment, and production support.
  • Excellent analytical, troubleshooting, communication, and stakeholder management skills.
Nice-to-have Skills:
  • Experience integrating TrackWise with SAP.
  • Experience with TrackWise Quality View.
  • Medical Device or Life Sciences industry experience.
  • Experience working with validation documentation and regulated software implementations.
  • Experience mentoring team members and contributing to knowledge management initiatives.


ABOUT AKRAYA
Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)!

Industry Leaders in Tech Staffing
As Talent solutions provider for Fortune 100 Organizations, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires!

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About the Company

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Akraya, Inc.