Senior QMS Systems Analyst - Compliance & Process Leader

STAAR Surgical Company; Lake Forest (CA); Vor Ort; USD 130.000 - 165.000; Vollzeit

Zusammenfassung

STAAR Surgical seeks a senior IT role focused on implementing and supporting an enterprise Quality Management System (QMS) using ComplianceQuest on the Salesforce Platform. The incumbent will partner with QA, Regulatory, Manufacturing, and IT to design, implement, and validate scalable QMS processes in a regulated medical device environment.

Required 8–10 years in QMS, 5+ years with ComplianceQuest, and familiarity with FDA/ISO/GxP requirements.

Qualifikationen

• 8–10 years implementing and supporting enterprise Quality Management Systems.
• 5+ years implementing and supporting ComplianceQuest.
• Experience with FDA-regulated medical devices; Salesforce Platform.
• Strong analytical, communication, and stakeholder management skills.
• Willingness to travel occasionally.

Aufgaben

• 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.
• 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.
• Prepare and review validation documentation and testing evidence.
• Ensure compliance with FDA 21 CFR Part 11, EU MDR, etc.

Kenntnisse

Quality Management Systems

FDA/GxP regulatory

Stakeholder management

Travel flexibility

Ausbildung

Bachelor's degree

Master's degree preferred

ComplianceQuest/Salesforce certs desirable

Tools

ComplianceQuest

Salesforce Platform

Jobbeschreibung

STAAR Surgical seeks a senior IT role focused on implementing and supporting an enterprise Quality Management System (QMS) using ComplianceQuest on the Salesforce Platform. The incumbent will partner with QA, Regulatory, Manufacturing, and IT to design, implement, and validate scalable QMS processes in a regulated medical device environment.

Required 8–10 years in QMS, 5+ years with ComplianceQuest, and familiarity with FDA/ISO/GxP requirements.