Quality Systems Specialist - QMS & CAPA Expert

6240-AMO Manufacturing USA LLC Legal Entity; Milpitas (CA); On-site; USD 75,000 - 121,000; Full time

Job summary

Johnson & Johnson in Milpitas, CA is recruiting a Quality System Specialist to support the administration, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with FDA QMSR and ISO 13485.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations and Supply Chain to ensure effective QMS processes, document control, CAPA, audits, training, metrics, and audit readiness.

Qualifications

• 2-5 years of experience in Quality Assurance, Regulatory Compliance, or related functions within a regulated industry.
• Medical Device industry experience preferred.
• Experience with FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP and related quality system requirements.
• Experience with eQMS, SAP, ETQ or similar systems preferred.
• Strong project management, organization, and prioritization skills.

Responsibilities

• Prepare and maintain monthly and quarterly metrics, dashboards, trend analyses, and performance reports.
• Coordinate and support QMSR activities, data collection, and action tracking.
• Facilitate NC, CAPA, and Change Control processes with investigations and root-cause analysis.
• Administer document control and records management within electronic systems.
• Assist with internal and external audits and regulatory inspections.

Skills

Quality Assurance

Regulatory Compliance

Cross-functional collaboration

Project management

Analytical thinking

Education

Bachelor's degree

Tools

eQMS

Agile PLM

SAP

ETQ

ComplianceWire

Job description

Johnson & Johnson in Milpitas, CA is recruiting a Quality System Specialist to support the administration, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with FDA QMSR and ISO 13485.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations and Supply Chain to ensure effective QMS processes, document control, CAPA, audits, training, metrics, and audit readiness.