Director, Quality Engineering — Production & Compliance

Terumo Neuro; Aliso Viejo (CA); On-site; USD 180,000 - 225,000; Full time

Job summary

Terumo Neuro is seeking a Director of Quality Engineering Production Support to lead strategic quality initiatives for medical device manufacturing. The role drives product quality, compliance, and continuous improvement across Manufacturing, R&D, Regulatory and Quality groups, with ownership of NCR processes and KPI reporting.

You will manage managers, engineers, and technicians, define functional goals, oversee budgets, and support audits while collaborating to enable process changes, design

Qualifications

• Experience leading quality engineering in medical devices.
• Strong knowledge of GMP/ISO quality systems.
• Experience owning NCR processes and KPI reporting.

Responsibilities

• Develop and implement strategies to enhance product quality and compliance.
• Lead multiple quality operations projects supporting medical device manufacture.
• Collaborate with Manufacturing, R&D, Regulatory and other Quality areas.
• Own and close NCR actions, implement corrective actions and monitor performance.
• Define team goals, budget, and resource allocation.
• Prepare for and support internal and external inspections as SME.
• Escalate issues and drive improvements in workflows and ERP processes.

Skills

Leadership

Quality Engineering

NCR/CAPA management

Cross-functional collaboration

Tools

ERP system

Job description

Terumo Neuro is seeking a Director of Quality Engineering Production Support to lead strategic quality initiatives for medical device manufacturing. The role drives product quality, compliance, and continuous improvement across Manufacturing, R&D, Regulatory and Quality groups, with ownership of NCR processes and KPI reporting.

You will manage managers, engineers, and technicians, define functional goals, oversee budgets, and support audits while collaborating to enable process changes, design