Director, Quality Engineering Production Support

Job overview

The Director, Quality Engineering Production Support role is onsite in Aliso Viejo, CA, five days per week. Compensation is not specified. The role supports the manufacture of medical devices and works with Manufacturing, Research and Development, Regulatory, and other Quality teams. This director leads quality engineering operations and develops strategies and processes that strengthen product quality and regulatory compliance. The role oversees nonconformance resolution, quality improvement, manufacturing changes, and team performance to support reliable medical-device production and the organization’s quality objectives.

What you'll do

• Develop and implement strategies to enhance product quality and compliance
• manage managers, engineers, and technicians supporting medical-device manufacturing
• oversee quality engineering work with Manufacturing Engineering and R&D on process changes and quality issues
• lead investigation and corrective actions for nonconforming products and customer complaints
• improve the quality management system
• execute product holds to prevent release of nonconforming goods
• support inspections as a subject matter expert
• manage functional budget and resource allocation
• escalate quality and compliance issues
• improve ERP workflows for product holds, traceability, and materials management.

What we're looking for

Skills & competencies

terumo neuro

quality engineering

medical devices

production support

quality management system

fda requirements

iso quality systems

nonconformance

corrective actions

aliso viejo ca

onsite

Work arrangement

• Weekend coverage required

Why this role

Leads quality engineering production support for medical devices, including ownership of the product non-conformance procedure.

About the employer

Terumo Neuro is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.