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Sr. TrackWise Consultant
Job in
Mountain View, Santa Clara County, California, 94043, USA
Listed on 2026-07-25
Listing for:
Akraya, Inc.
Full Time
position Listed on 2026-07-25
Job specializations:
-
IT/Tech
IT Business Analyst, Data Analyst
Job Description & How to Apply Below
Primary Skills: Track Wise Configuration (Expert), Track Wise 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 Track Wise Consultant to support the design, configuration, enhancement, and implementation of Track Wise Quality Management System (QMS) solutions for a leading medical device organization. The ideal candidate will have extensive experience with Track Wise 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 Track Wise solutions to support Quality Management processes.
- Configure Track Wise workflows, business rules, forms, notifications, automation, and system enhancements.
- Develop and maintain Track Wise 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.
- 8+ years of hands-on Track Wise System Analysis and Configuration experience.
- Strong expertise in Track Wise Configuration, workflows, business rules, TWC automation, and notifications.
- Experience developing Track Wise 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.
- Experience integrating Track Wise with SAP.
- Experience with Track Wise 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.
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 Work spaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)!
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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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