Quality Lead

ClinDCast, LLC; Northern (KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

ClinDCast, LLC is seeking a Quality Lead to support 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.

You will conduct root cause analyses, drive corrective actions, analyze quality metrics, and support FDA readiness.

Qualifications

• CAPA, Nonconformance, and Deviation Management.
• Root Cause Analysis using 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.
• Experience with Class II/III medical devices and audits.

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.

Skills

CAPA/NCR management

Root Cause Analysis

Quality metrics & trends

FDA 21 CFR 820

ISO 13485 & ISO 14971

Design Controls & Validation

Education

Bachelor's degree in Engineering or related discipline

Job description

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.

ClinDCast offers Healthcare IT solutions and consulting services to payers, providers and life sciences organizations enabling them to enhance care delivery to patients.