Quality Ops Manager

Quality Operations Manager — Apex Medical Devices

Charlotte, NC | January 2023 – Present

• Led a team of 8 quality inspectors to audit and optimize assembly line workflows, reducing component defect rates by 28% utilizing Minitab statistical process control.
• Re-engineered the Corrective and Preventive Action (CAPA) tracking workflow in Qualio QMS, reducing average issue resolution times from 42 days to 24 days.
• Spearheaded preparation for 3 external ISO 13485 registration audits, achieving 100% certification retention with zero major non-conformances identified.
• Automated receiving inspection logging via Arena PLM, cutting manual database entry errors by 45% and saving over 12 hours of weekly administrative labor.

Quality Operations Specialist — Vanguard Precision Aerospace

Greenville, SC | August 2020 – December 2022

• Standardized incoming material inspections for 14 supplier accounts, reducing raw material rejection discrepancies by 32% utilizing established AS9100 standards.
• Analyzed production line scrap data using Six Sigma Pareto charting, identifying root causes that saved more than $95,000 in raw material waste over 18 months.
• Coordinated weekly root cause analysis (RCA) workshops for 24 fabrication operators, reducing assembly re-work requirements by 21% using Ishikawa diagrams.
• Authored 18 standard operating procedures (SOPs) for cleanroom operations, improving new-hire quality training compliance scores from 78% to 98% over a 6-month period.

Statistical Process Control (SPC), CAPA Management, ISO 9001:2015, ISO 13485, Root Cause Analysis (RCA), Six Sigma Green Belt, Supplier Quality Auditing, FMEA (Failure Mode and Effects Analysis), Minitab, Qualio QMS, Arena PLM, Jira, Lean Manufacturing, Gauge R&R, Process Validation (IQ/OQ/PQ)

QMS Cloud Migration Initiative

Role: Lead Quality Systems Manager

Tools: Qualio QMS, Arena PLM, Microsoft Project

Directed the migration of 4,200 paper quality records to a cloud-based QMS platform, reducing document retrieval times by 75% and achieving full FDA 21 CFR Part 11 compliance.

Supplier Quality Standardization Project

Role: Quality Operations Manager

Tools: Minitab, Microsoft Excel, Sharepoint

Audited and re-qualified 15 critical raw material suppliers, standardizing incoming inspection protocols and reducing vendor-related defects by 40% in 9 months.

• Certified Manager of Quality/Organizational Excellence (CMQ/OE) - ASQ (2024)
• Six Sigma Green Belt - ASQ (2021)
• ISO 9001:2015 Lead Auditor - Exemplar Global (2022)

• Languages: English (Native), German (Conversational)
• Volunteer Work: Quality management mentor for regional manufacturing apprentice programs (2023–Present)
• Availability: 3 weeks notice