Quality Manager

Katalyst CRO; Greensboro (NC); On-site; USD 120,000 - 190,000; Full time

Job summary

Katalyst CRO in Greensboro, NC seeks an experienced Quality Leadership professional to lead remediation and compliance programs for medical device quality systems. You will oversee CAPA, nonconformance, complaints and audit programs while supporting FDA inspections and global regulatory audits.

The role requires 12+ years of medical device quality experience with 5+ years in quality management leadership, and a strong background in ISO 13485 and FDA regulations.

Qualifications

• Medical Device QMS experience.
• CAPA, Nonconformance, Complaint, and Audit management.
• Familiar with FDA 21 CFR Part 820/QMSR and ISO 13485.
• Experience in risk management and design controls.
• Knowledge of quality metrics, remediation and compliance programs.

Responsibilities

• Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
• Support FDA inspections and regulatory audits.
• Drive quality remediation and compliance initiatives.
• Monitor quality metrics and management reviews.
• Lead cross-functional quality improvement activities.

Skills

QMS

CAPA & Audit

FDA 21 CFR 820

Risk Management

Quality Metrics

Education

Bachelor's or Master's in Engineering

Job description

Job Summary

Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.

Responsibilities

• Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
• Support FDA inspections and regulatory audits.
• Drive quality remediation and compliance initiatives.
• Monitor quality metrics and management reviews.
• Lead cross-functional quality improvement activities.

Required Skills

• Medical Device Quality Management Systems (QMS).
• CAPA, Nonconformance, Complaint, and Audit Management.
• FDA 21 CFR Part 820/QMSR and ISO 13485.
• Risk Management and Design Controls.
• Quality Metrics, Remediation, and Compliance Programs.

Preferred Qualifications

• Bachelor's or master's degree in engineering or related discipline.
• 12+ years of Medical Device Quality experience.
• 5+ years of Quality Management leadership experience.
• ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
• Experience supporting FDA inspections and remediation programs