Location: Monrovia and/or Lake Forest
MAIN JOB RESPONSIBILITIES / COMPETENCIES
Reporting to the Sr. Director IT - Enterprise Applications, the incumbent will partner with Quality Assurance, Regulatory Affairs, Manufacturing, Supplier Quality, Operations, and IT to design, implement, enhance, and support the enterprise Quality Management System (QMS) using ComplianceQuest on the Salesforce Platform. The role will provide functional leadership for Quality business processes while ensuring compliance with FDA, ISO, GxP, and corporate quality requirements. The position will collaborate with cross-functional business teams to optimize quality processes, implement scalable solutions, support global Quality initiatives, and ensure system compliance in a regulated medical device environment.
Essential Functions and Responsibilities
Business Analysis
• Partner with Quality, Regulatory Affairs, Manufacturing, Supplier Quality, Engineering, and IT stakeholders to analyze and document business requirements.
• Lead business process workshops and identify opportunities for process improvements.
• Recommend ComplianceQuest best practices and scalable Quality Management solutions.
• Drive process standardization across global Quality functions.
ComplianceQuest Functional Support
• Provide functional ownership of ComplianceQuest Quality Management modules including:
o CAPA
o Nonconformance (NCR)
o Complaint Management
o Audit Management
o Change Management
o Document Control
o Training Management
o Supplier Quality
o Risk Management
o Equipment Management
o Inspection Management
o Design Controls
Solution Design
• Configure ComplianceQuest applications based on business requirements.
• Develop functional specifications and configuration documentation.
• Support integrations with Oracle Fusion ERP, Salesforce, Oracle Integration Cloud (OIC), PLM, MES, and other enterprise systems.
• Participate in architecture and solution design reviews.
Testing & Production Support
• Lead System Integration Testing (SIT) and User Acceptance Testing (UAT).
• Coordinate defect triage and resolution.
• Support quarterly ComplianceQuest and Salesforce releases.
• Lead troubleshooting and root cause analysis.
• Identify continuous improvement opportunities.
Governance & Compliance
• Support Computer Software Assurance (CSA) and Computer System Validation (CSV).
• Prepare and review validation documentation and testing evidence.
• Ensure solution comply with standards - FDA 21 CFR Part 11, EU MDR, etc
• Ensure compliance with Change Management processes.
Documentation & Training
• Develop SOPs, Work Instructions, configuration documentation, and knowledge articles.
• Deliver end-user and super-user training.
• Maintain Quality System documentation.
Other duties as assigned.
REQUIREMENTS
EDUCATION & TRAINING
• Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, Quality, or related field.
• Master's degree preferred.
• ComplianceQuest and Salesforce certifications are highly desirable.
EXPERIENCE
• 8-10 years implementing and supporting enterprise Quality Management Systems.
• 5+ years implementing and supporting ComplianceQuest.
• Functional expertise in CAPA, Nonconformance, compliant management, audit management, change control, document control, supplier quality, training and risk management.
• Experience supporting FDA-regulated medical device organizations.
• Experience with Salesforce Platform.
• Experience supporting GxP Computer Software Assurance (CSA) or CSV.
SKILLS
• Deep functional knowledge of Quality Management Systems.
• Strong understanding of FDA, ISO 13485, ISO 14971, EU MDR, and MDSAP regulations.
• Excellent analytical, communication and stakeholder management skills.
• Ability to manage multiple projects and mentor junior analysts.
• Willingness to travel occasionally.
Preferred Certifications
• ComplianceQuest Administrator
• Salesforce Administrator
• Salesforce Business Analyst
Pay range: $130K - $165K - Final compensation/salary will depend on experience.
