Quality Systems Manager

Quality Systems Manager — AeroCore Manufacturing

Austin, TX | January 2024 – Present

• Directed 2 QMS compliance teams of 7 quality specialists to implement automated document control workflows, reducing document approval cycle times by 32% and saving 14 hours per week.
• Designed and audited 4 new corporate quality manuals in alignment with ISO 9001 standards, decreasing internal audit non-conformances by 28% across 3 manufacturing facilities.
• Managed supplier quality audits for 35 external component vendors, implementing corrective action plans (CAPA) that reduced incoming raw material defect rates by 19% over a 12-month period.
• Collaborated with engineering to establish validation protocols for 12 new product launches, successfully lowering post-market compliance issues from 7% to under 1.5%.

Senior Quality Systems Specialist — Vanguard Health Systems

Dallas, TX | August 2020 – December 2023

• Engineered and maintained 15 core quality management system databases, decreasing reporting delays by 22% and improving user access management efficiency by 18%.
• Audited production assembly steps for 5 major product families, correcting 28 non-compliance findings and reducing final product rejection rates by 14% on the main lines.
• Coordinated with 8 engineering teams to track and resolve 140 deviation reports using TrackWise, reducing the average resolution time for corrective actions by 35%.
• Mentored 3 junior quality technicians on calibration testing and auditing procedures, helping improve overall team certification exam success rates by 25%.

ISO 9001 standards, ISO 13485 compliance, Quality Management Systems (QMS), Corrective and Preventive Action (CAPA), Document control, Audit management, TrackWise, Veeva Vault QMS, SAP ERP, Minitab, Supplier quality management, Root cause analysis (RCA), Process validation, Calibration systems, Continuous improvement

QMS Veeva Vault Integration

Role: Lead QMS System Administrator

Tools: Veeva Vault, SAP ERP, TrackWise, SharePoint

Led the 9-month migration of all legacy quality documentation to Veeva Vault QMS, transitioning 400+ users and reducing file retrieval times by 45%.

Supplier Quality Standardization

Role: Quality Systems Audit Lead

Tools: TrackWise, Minitab, Excel VBA

Created a standardized scorecard system for 50 critical component suppliers, improving on-time compliance submittals by 30% and saving $75,000 in reinspection fees.

• ASQ Certified Quality Auditor (CQA) (2023)
• ISO 9001:2015 Lead Auditor Certification (2021)
• ASQ Certified Quality Manager (CMQ/OE) (2024)

• Languages: English (Native), French (Conversational)
• Volunteer Work: Regional safety inspector for youth robotics programs (2022-present)
• Availability: 2 weeks notice