Quality Manager (Regulated Industry)

Job overview

The Quality Manager (Regulated Industry) role is onsite in Durham, NC. Compensation is not specified. Mentor Technical Group provides technical support and solutions for FDA-regulated industries, including pharmaceutical, biotechnology, and medical-device clients. The manager leads quality-system execution and compliance for assigned client facilities, overseeing audits, investigations, training, documentation, corrective actions, and continuous improvement. The role helps clients meet regulatory and customer requirements through effective quality processes and oversight.

What you'll do

• Establish and oversee quality management systems
• lead events and root-cause analysis
• oversee training, inspection readiness, and vendor management
• develop strategies to meet client requirements
• support quality-system processes and procedure changes
• analyze quality data
• oversee documentation review and approval
• review protocols and reports
• manage CAPAs, non-conformances, complaints, audits, and investigations
• lead continuous-improvement projects across multiple sites
• coordinate with customers, suppliers, and internal teams. Travel to support clients and operations as required.

What we're looking for

Skills & competencies

quality manager

regulated industry

durham nc

mentor technical group

quality management systems

fda-regulated industry

compliance

audits

capa

root-cause analysis

gmp

gdp

iso standards

english and spanish

Work arrangement

• Weekend coverage required

Why this role

Requires English and Spanish communication and technical writing skills; travel to support clients and operations as required.

About the employer

Mentor Technical Group is hiring for this role. Industry: Other Scientific and Technical Consulting Services. Sector: 54.