QMS Solutions Lead: ComplianceQuest on Salesforce

STAAR Surgical; Lake Forest (CA); On-site; USD 130,000 - 165,000; Full time

Job summary

STAAR Surgical seeks an experienced IT professional to design, implement, and support the enterprise Quality Management System (QMS) using ComplianceQuest on Salesforce. You will lead cross-functional teams to ensure FDA/GxP compliance and drive scalable quality processes in a regulated medical device environment.

The role involves configuring CQ, integrating with Oracle/Salesforce ecosystems, and coordinating testing, validation, and training activities across Monrovia and Lake Forest sites.

Qualifications

• 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.

Responsibilities

• 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.
• Provide functional ownership of ComplianceQuest Quality Management modules including CAPA, NCR, Complaint Management, Audit Management, Change Management, Document Control, Training Management, Supplier Quality, Risk Management, Equipment Management, Inspection Management, Design Controls.
• 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.
• 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.
• Support CSA and CSV validation activities.
• Prepare and review validation documentation and testing evidence.
• Ensure compliance with FDA 21 CFR Part 11, EU MDR, etc
• Ensure compliance with Change Management processes.
• Develop SOPs, Work Instructions, configuration documentation, and knowledge articles.
• Deliver end-user and super-user training.
• Maintain Quality System documentation.

Skills

Quality management

FDA compliance

Stakeholder management

Analytical thinking

Project leadership

GxP/regulatory knowledge

Education

Bachelor's degree in Information Systems, CS, Engineering, Life Sciences, Quality or related field

Master's degree preferred

ComplianceQuest/Salesforce certifications desirable

Tools

ComplianceQuest

Salesforce Platform

Oracle Fusion ERP

Oracle Integration Cloud (OIC)

PLM/MES integrations

Job description

STAAR Surgical seeks an experienced IT professional to design, implement, and support the enterprise Quality Management System (QMS) using ComplianceQuest on Salesforce. You will lead cross-functional teams to ensure FDA/GxP compliance and drive scalable quality processes in a regulated medical device environment.

The role involves configuring CQ, integrating with Oracle/Salesforce ecosystems, and coordinating testing, validation, and training activities across Monrovia and Lake Forest sites.