No Corp-to-corp. No 3rd party firms
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Position: QMS Business System Analyst (ComplianceQuest)
Location: 4-day onsite in Irvine, CA (Only local candidates will be considered)
Terms: Direct-hire
Compensation: $130,000 to $165,000 + benefits
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About the Role
We are partnered with a client seeking an experienced Business Systems Analyst (QMS) to lead the support, enhancement, and optimization of our enterprise Quality Management System powered by ComplianceQuest on the Salesforce Platform. This role serves as a key liaison between Quality, Regulatory Affairs, Manufacturing, Operations, and IT, helping deliver scalable, compliant, and efficient solutions in a regulated medical device environment.
What You'll Do
- Partner with Quality, Regulatory, Manufacturing, Engineering, and Operations teams to gather business requirements and improve quality processes.
- Configure, enhance, and support ComplianceQuest applications to meet business and regulatory needs.
- Provide functional expertise across key QMS processes including CAPA, Nonconformance, Complaints, Audits, Change Control, Document Control, Training, Supplier Quality, and Risk Management.
- Drive process standardization and continuous improvement initiatives across global quality functions.
- Support integrations between ComplianceQuest, Salesforce, Oracle Fusion ERP, Oracle Integration Cloud (OIC), and other enterprise platforms.
- Lead testing activities, including System Integration Testing (SIT) and User Acceptance Testing (UAT).
- Coordinate issue resolution, release management, and ongoing production support.
- Ensure compliance with FDA, ISO 13485, EU MDR, GxP, CSA/CSV, and other regulatory requirements.
- Create and maintain system documentation, SOPs, training materials, and knowledge resources.
- Deliver end-user training and support adoption of new system capabilities.
What We're Looking For
- Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, Quality, or a related field.
- 8+ years of experience supporting enterprise Quality Management Systems.
- 5+ years of hands-on ComplianceQuest experience.
- Strong understanding of QMS processes, including CAPA, NCR, Audit Management, Change Control, Document Control, Supplier Quality, Training, and Risk Management.
- Experience working within FDA-regulated medical device, life sciences, or other highly regulated environments.
- Experience with Salesforce and enterprise system integrations.
- Knowledge of Computer Software Assurance (CSA) and Computer System Validation (CSV) methodologies.
- Excellent communication, stakeholder management, and problem-solving skills.
Preferred Qualifications
- ComplianceQuest Administrator Certification
- Salesforce Administrator Certification
- Salesforce Business Analyst Certification
- Experience supporting global quality organizations and digital transformation initiatives
Join a growing team where you'll play a critical role in advancing quality excellence, regulatory compliance, and business process innovation through modern QMS technology solutions.
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All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.