Quality Assurance Coordinator - Medica Device

📋 Description

• Review incoming batch records for release readiness.
• Ensure QC testing complete before batchRelease.
• Review Quality System for open NCMs/CAPAs tied to batch.
• Initiate, monitor, and review NCMs and CAPAs.
• Support risk assessments and failure investigations.
• Assist KPI/metric data collection and improvement efforts.

🎯 Requirements

• FDA/ISO/cGMP regulations familiarity.
• BS in life science or engineering preferred.
• Lean/Six Sigma experience; Green/Black Belt preferred.
• Quality audit process understanding; internal auditor a plus.
• KPI/metric development and tracking experience.
• 2+ years in manufacturing/quality in regulated industry.

🎁 Benefits

• Competitive compensation and performance bonus.
• PTO, holidays, floating holidays.
• Healthcare benefits, HSA match, 401k match.
• Wellness discounts and additional perks.