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Sr. TrackWise Consultant : 26-02120

Sunnyvale, CA 94043

Posted: 08/06/2026 Job Category: Software Engineering & Development Job Number: 26-02120 Country: US

Job Description

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.


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About Sunnyvale, CA

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