Quality Systems Specialist – Medical Devices & Compliance

Johnson Johnson; Milpitas (CA); On-site; USD 80,000 - 125,000; Full time

Job summary

Johnson & Johnson in Milpitas, CA, is seeking a Quality System Specialist to support the administration, maintenance, and improvement of the QMS to ensure compliance with FDA QSR, ISO 13485, and internal policies.

You will work cross-functionally with Quality, Regulatory Affairs, Manufacturing, Engineering, and IT to implement and monitor QMS processes, manage document control, CAPA, change control, audits, and training.

Qualifications

• Bachelor or equivalent degree in science, engineering, or related field.
• Experience in Quality Assurance or regulatory compliance in a regulated industry.
• Experience in FDA-regulated environments preferred.
• Knowledge of QMS, CAPA, change control and document control processes.

Responsibilities

• Prepare monthly and quarterly metrics and dashboards.
• Support QSMR activities, data collection, and action items.
• Facilitate NC/CAPA and change control processes.
• Administer QMS document control and records management.
• Assist internal/external audits and regulatory inspections.
• Analyze quality data to identify risks and improvement opportunities.
• Collaborate with cross-functional teams to improve QMS processes.
• Support audit readiness programs.

Skills

Quality Assurance

Regulatory Compliance

Document Control

CAPA

Audit Management

FDA/QMSR knowledge

Project Management

Education

Bachelor's degree

Tools

QMS software

SAP

ETQ

ComplianceWire

Agile PLM

Job description

Johnson & Johnson in Milpitas, CA, is seeking a Quality System Specialist to support the administration, maintenance, and improvement of the QMS to ensure compliance with FDA QSR, ISO 13485, and internal policies.

You will work cross-functionally with Quality, Regulatory Affairs, Manufacturing, Engineering, and IT to implement and monitor QMS processes, manage document control, CAPA, change control, audits, and training.