Quality Systems Manager

Job overview

The Quality Systems Manager role is onsite in Irvine, CA, and pays $100,000–$145,000 per year. The position supports Nihon Kohden America’s medical-device quality systems and regulatory compliance. The manager maintains an effective, compliant, and inspection-ready quality management system through audits, corrective and preventive actions, document controls, metrics, and continuous improvement. The role helps the organization meet regulatory requirements and quality objectives while supporting external audits and inspections.

What you'll do

• Manage the Quality Management System and regulatory compliance
• oversee internal audits and facilitate external audits and inspections
• supervise CAPA and nonconformance programs, including investigations and root-cause analysis
• oversee change control, document control, and records management
• monitor QMS metrics and prepare management-review reports
• partner with departments on compliance initiatives and training
• lead and develop Quality Systems personnel
• support batch-record review and approval as needed.

What we're looking for

Skills & competencies

quality systems manager

quality management system

medical devices

regulatory compliance

capa

internal audits

iso 13485

irvine ca

nihon kohden america

$100k–$145k

monday–friday

Work arrangement

• Weekend coverage required

Benefits & perks

• The posting directs applicants to the company career page for details about perks and benefits.

Why this role

Medical-device quality systems leadership with knowledge of GxP, ISO 13485, ISO 14971, and FDA 21 CFR 820; regular hours are stated as 8:00 a.m.–5:00 p.m., Monday–Friday, with weekend, holiday, or evening work potentially required.

About the employer

Nihon Kohden America, LLC is hiring for this role. Industry: Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables. Sector: 33.