QMS & ComplianceQuest Analyst (Salesforce)

Ledgent Technology; Irvine (CA); On-site; USD 145,000 - 165,000; Full time

Job summary

Ledgent Technology in Irvine, CA, seeks an experienced Business Systems Analyst (QMS) to lead the support, enhancement, and optimization of a ComplianceQuest-based QMS on the Salesforce Platform. This role bridges Quality, Regulatory, Manufacturing, Operations, and IT to deliver scalable, compliant solutions in a regulated medical device environment.

Responsibilities include gathering requirements with cross-functional teams, configuring ComplianceQuest, supporting CAPA, Change Control, Audit

Qualifications

• Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, Quality, or related field.
• 8+ years supporting enterprise Quality Management Systems.
• 5+ years hands-on ComplianceQuest experience.
• Experience with FDA-regulated medical device environments and system integrations.

Responsibilities

• Gather requirements with Quality, Regulatory, Manufacturing, and IT teams.
• Configure, enhance, and support ComplianceQuest applications.
• Provide functional expertise across CAPA, Nonconformance, Audits, Change Control, Document Control, Training, Supplier Quality, and Risk Management.
• Coordinate SIT/UAT, testing, and issue resolution; manage releases and production support.
• Ensure compliance with FDA, ISO 13485, EU MDR and other regulatory requirements.

Skills

QMS knowledge

ComplianceQuest

Salesforce integration

Regulatory compliance

Stakeholder management

Education

Bachelor's degree in Information Systems / CS / Engineering / Life Sciences / Quality

Tools

ComplianceQuest

Salesforce

Oracle Fusion ERP

Oracle Integration Cloud (OIC)

Job description

Ledgent Technology in Irvine, CA, seeks an experienced Business Systems Analyst (QMS) to lead the support, enhancement, and optimization of a ComplianceQuest-based QMS on the Salesforce Platform. This role bridges Quality, Regulatory, Manufacturing, Operations, and IT to deliver scalable, compliant solutions in a regulated medical device environment.

Responsibilities include gathering requirements with cross-functional teams, configuring ComplianceQuest, supporting CAPA, Change Control, Audit