Director, Quality Engineering Production Support

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

Director, Quality Engineering Production Support

Position Overview

Develop and implement strategies to enhance product quality and compliance. Manage team members to lead multiple quality operations projects that support the manufacture of medical devices. Assist executives and/or senior directors in defining organizational goals and strategic plans. Collaborate closely with management and staff in Manufacturing, R&D, Regulatory, and other Quality areas to support manufacturing process changes, manufacturing transfers, product design improvements and transfers, implementation of new products, and the enhancement of quality management system compliance. As owner of product non-conformance procedure, responsible for timely execution and closure, implementation of actions, corrections, material disposition, monitoring performance of the NCR process, and providing KPI’s to the Quality Leadership team.

• Working with senior quality management, develop and implement strategies to enhance product quality and compliance
• 2. Develop guidelines and complex processes/procedures for quality engineering groups to enhance performance
• 3. Manage managers, engineers, and technicians who support the manufacture of medical devices
• 4. Manage managers and quality engineers who work with Manufacturing Engineering and R&D to review process changes and resolve quality issues
• 5. Manage quality engineers who lead activities to investigate corrective actions associated with nonconforming product and customer complaints
• 6. Manage quality engineers who lead projects to improve the quality management system, including remediation projects and cost reduction opportunities
• 7. Execute product holds in the system to prevent inadvertent release of non-conforming goods
• 8. Coordinate and execute activities related to Engineering Order, Quality Plan, Quality Improvement Project to support business needs, corporate strategies, and Global Quality objectives
• 9. Effectively communicate and collaborate with other departments as needed to achieve Quality Engineering and company goals
• 10. Resolve critical issues and contribute to organizational development
• 11. Define functional goals and objectives for the team and monitor performance throughout the year
• 12. Make strategic decisions based on company goals and objectives
• 13. Support internal and external inspections as Subject Matter Expert in front room
• 14. Control functional budget and expenses and responsible for resource allocation
• 15. Escalate quality and compliance issues to senior quality management and propose and work on effective solutions
• 16. Contribute to the design and improvements of workflows in the ERP software for processes related to product hold, traceability, and materials management
• 17. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
• 18. Perform additional duties as assigned

Job ID 15046BR

Salary Range:

$179,788 - $224,735 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand