Quality Systems Leader | Compliance & Improvement

Nihon Kohden America; Irvine (CA); On-site; USD 100,000 - 145,000; Full time

Job summary

Nihon Kohden America in Irvine, CA seeks a Quality Systems Manager to lead the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and company policies. The role focuses on proactive monitoring, auditing, quality metrics, and continuous improvement initiatives.

The position requires strong leadership, project management, and working knowledge of medical device quality system regulations, with responsibilities spanning audits, CAPA, change control, document

Qualifications

• Bachelor’s degree in a Science, Technology, Engineering, Mathematics (STEM) field or related discipline.
• 6+ years in medical device or pharmaceutical industry.
• 2+ years people management experience.
• Quality certifications preferred (CQA, CQE, CMQ/OE).
• Strong knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820.

Responsibilities

• Manage the Quality Management System (QMS) ensuring regulatory compliance and company policies.
• Manage Internal Audit program; facilitate external audits and ensure timely closure of findings.
• Oversee CAPA and Nonconformance programs including root cause analysis and effectiveness verification.
• Oversee Change Control, Document Control, and Records Management to maintain controlled documentation.
• Monitor QMS performance via metrics and Management Review; drive quality improvement and inspection readiness.
• Provide training and quality systems support across functions.
• Lead and develop Quality Systems personnel; manage team performance and succession planning.
• Support batch record review and approval as needed.

Skills

Quality systems

Project management

Leadership

Regulatory knowledge

Education

Bachelor’s degree in STEM

Tools

Configuration Management

Learning Management Systems

Job description

Nihon Kohden America in Irvine, CA seeks a Quality Systems Manager to lead the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA regulations, and company policies. The role focuses on proactive monitoring, auditing, quality metrics, and continuous improvement initiatives.

The position requires strong leadership, project management, and working knowledge of medical device quality system regulations, with responsibilities spanning audits, CAPA, change control, document