Quality Systems Leader: Drive Compliance & Improvement

Nihon Kohden North America, Inc.; Irvine (CA); Hybrid; USD 100.000 - 145.000; Vollzeit

Zusammenfassung

Nihon Kohden America is seeking a Quality Systems Manager to maintain an effective QMS, lead audits, and drive continuous improvement across departments in Irvine, CA.

You will oversee CAPA, change control, and document control while ensuring compliance with ISO 13485, FDA regulations, and other applicable standards. Strong leadership and project management are essential in this regulatory-focused role.

Qualifikationen

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

Aufgaben

• Manage QMS ensuring ongoing effectiveness and regulatory compliance.
• Oversee Internal Audit program and facilitate external audits.
• Lead CAPA and Nonconformance investigations from root cause to closure.
• 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.

Kenntnisse

Leadership

Project Management

Cross-functional Collaboration

Quality Systems Knowledge

Regulatory Compliance

Communication

Problem Solving

Strategic Thinking

Documentation

Ausbildung

Bachelor's degree in STEM

Tools

Configuration Management

Learning Management Systems

Jobbeschreibung

Nihon Kohden America is seeking a Quality Systems Manager to maintain an effective QMS, lead audits, and drive continuous improvement across departments in Irvine, CA.

You will oversee CAPA, change control, and document control while ensuring compliance with ISO 13485, FDA regulations, and other applicable standards. Strong leadership and project management are essential in this regulatory-focused role.