Quality Systems Leader, Medical Devices

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

Job summary

Nihon Kohden America is seeking a Quality Systems Manager to maintain a compliant QMS, drive continuous improvement, and support external audits. The role partners with cross-functional teams to resolve quality issues and enhance inspection readiness.

Responsibilities include overseeing CAPA, change and document control, metrics reviews, training, and people management. A STEM degree, 6+ years in medical device/pharma and knowledge of ISO/FDA regulations are required.

Qualifications

• Bachelor’s degree in STEM field.
• 6+ years in medical device or pharmaceutical industry.
• 2+ years of people management experience.
• Quality certifications such as CQA, CQE, CMQ/OE preferred.
• Strong knowledge of GxP, ISO 13485, ISO 14971 and FDA 21 CFR 820.
• Familiarity with Canadian Medical Devices Regulations SOR/98-282.
• Knowledge of Quality Systems Software: Configuration Management, LMS.
• Strong communication and leadership skills.

Responsibilities

• Manage Nihon Kohden America's QMS and maintain regulatory compliance.
• Oversee Internal Audit program and facilitate external audits.
• Lead CAPA and Nonconformance programs including root cause analysis.
• Oversee Change Control, Document Control, and Records Management.
• Monitor QMS performance via metrics and Management Review.
• Provide training and quality systems support across the organization.
• Lead Quality Systems personnel and manage team development.

Skills

Leadership

Regulatory knowledge

Quality systems

Communication

Strategic thinking

Education

Bachelor’s degree in STEM

CQA

CQE

CMQ/OE

Tools

Configuration Management

Learning Management Systems

Job description

Nihon Kohden America is seeking a Quality Systems Manager to maintain a compliant QMS, drive continuous improvement, and support external audits. The role partners with cross-functional teams to resolve quality issues and enhance inspection readiness.

Responsibilities include overseeing CAPA, change and document control, metrics reviews, training, and people management. A STEM degree, 6+ years in medical device/pharma and knowledge of ISO/FDA regulations are required.