Quality Manager, Medical Devices

Job overview

The Quality Manager, Medical Devices role is onsite in Greensboro, NC. Compensation is not specified. The role leads quality remediation and compliance programs for medical devices. The manager oversees quality management system processes, corrective and preventive action governance, audit readiness, and quality metrics. The work helps ensure adherence to FDA, ISO 13485, and global regulatory requirements while advancing cross-functional quality improvement.

What you'll do

• 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.

What we're looking for

Skills & competencies

quality manager

medical devices

greensboro nc

katalyst healthcares & life sciences

quality management system

capa

nonconformance

complaint management

audit readiness

fda inspections

iso 13485

quality remediation

regulatory compliance

full-time

Work arrangement

• Weekend coverage required

Why this role

Preferred qualifications include 12 years of medical device quality experience, five years of quality management leadership, and ISO 13485 Lead Auditor or ASQ/CQI certification.

About the employer

Katalyst Healthcares & Life Sciences is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.