Quality Lead

Job Summary

Seeking a Quality Lead to support quality remediation and compliance initiatives within the medical device industry. The role will manage CAPA, nonconformance, deviations, complaints, quality systems, root cause investigations, and quality improvement activities while ensuring regulatory compliance.

Key Responsibilities

• Manage CAPA, Nonconformance, Deviation, and Complaint activities.

• Conduct Root Cause Analysis and implement corrective actions.

• Analyze quality metrics and identify recurring issues/trends.

• Support quality audits and FDA readiness initiatives.

• Collaborate with cross-functional teams on quality improvements.

Required Skills

• CAPA, Nonconformance, and Deviation Management.

• Root Cause Analysis: 5 Why, Fishbone, FTA.

• Quality Metrics and Trend Analysis.

• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.

• Design Controls and Validation Support.

Preferred Qualifications

• Bachelor's degree in Engineering or related discipline.

• 8+ years of Medical Device Quality experience.

• Experience with Class II/III medical devices.

• Experience supporting FDA, MDSAP, and ISO audits.