Quality Systems Specialist: Drive QMS Excellence & Compliance

jj; Milpitas (CA); On-site; USD 75,000 - 121,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Paid vacation

Paid holidays

Parental Leave

Job summary

Johnson & Johnson is seeking a Quality System Specialist to support the administration, maintenance, and continuous improvement of the Quality Management System. The role collaborates with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations, and Supply Chain to ensure effective QMS implementation and audit readiness.

The position emphasizes document control, training management, CAPA, change control, and compliance with regulatory requirements in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific, engineering, business, or related discipline is required.
• Experience in FDA-regulated environments and ISO 13485 is preferred.
• 2-5 years in Quality Assurance or regulatory compliance within a regulated industry.

Responsibilities

• Prepare and maintain monthly and quarterly metrics, dashboards, trend analyses, and performance reports.
• Coordinate and support QMSR activities, data collection, metric analysis, and action-tracking.
• Facilitate NC, CAPA, and Change Control processes, investigations, root cause analysis, and verification of effectiveness.
• Support administration and monitoring of the QMS to ensure compliance with FDA QMSR and ISO 13485.
• Administer document control and records management within electronic systems.

Skills

QMS compliance

CAPA

Audit readiness

eQMS

Documentation

Cross-functional

MS Office

Education

Bachelor's degree in a relevant field

Tools

eQMS

Agile PLM

SAP

ETQ

ComplianceWire

Job description

Johnson & Johnson is seeking a Quality System Specialist to support the administration, maintenance, and continuous improvement of the Quality Management System. The role collaborates with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations, and Supply Chain to ensure effective QMS implementation and audit readiness.

The position emphasizes document control, training management, CAPA, change control, and compliance with regulatory requirements in a fast-paced environment.