Quality Systems Specialist - Drive Compliance & Improvement

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

Benefits offered by this job

Vacation 120 hours/yr

Sick time 40 hours/yr

Holiday pay 13 days/yr

Parental Leave 480 hours/yr

Volunteer Leave 32 hours/yr

Job summary

Johnson & Johnson is seeking a Quality System Specialist to support administration, maintenance, and continuous improvement of the Quality Management System (QMS). This role focuses on document control, CAPA, training management, audits, and cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, and Supply Chain to ensure compliance with FDA, ISO, and internal policies.

The position can be located in Milpitas, CA and requires experience in regulated environments, strong

Qualifications

• Bachelor's degree in a scientific, engineering, business, or related discipline (or equivalent experience).
• 2–5 years in Quality Assurance, Regulatory Compliance, or related regulated roles.
• Experience in FDA-regulated and ISO 13485 environments preferred.

Responsibilities

• Prepare monthly/quarterly metrics, dashboards, trend analyses, and reports.
• Support QMS review activities, data collection, and action tracking.
• Lead NC/CAPA and Change Control investigations and verification.
• Maintain documents and records in electronic systems with proper lifecycle management.
• Support internal, external, supplier audits and regulatory inspections.
• Analyze data to identify compliance risks and drive improvements.

Skills

Quality Assurance

Regulatory Compliance

Document Control

CAPA

Audit Management

eQMS

Change Control

FDA 21 CFR Part 820

Education

Bachelor's degree

Tools

SAP

ETQ

eQMS

ComplianceWire

Agile PLM

Job description

Johnson & Johnson is seeking a Quality System Specialist to support administration, maintenance, and continuous improvement of the Quality Management System (QMS). This role focuses on document control, CAPA, training management, audits, and cross-functional collaboration with Quality, Regulatory Affairs, Manufacturing, and Supply Chain to ensure compliance with FDA, ISO, and internal policies.

The position can be located in Milpitas, CA and requires experience in regulated environments, strong