Quality Systems Specialist: Drive Compliance & Improvement

Johnson & Johnson Innovation; Milpitas (CA); On-site; USD 75,000 - 121,000; Full time

Job summary

Johnson & Johnson is seeking a Quality System Specialist to support administration, maintenance, and continuous improvement of the Quality Management System (QMS) ensuring compliance with FDA QMSR, ISO 13485, and company policies. This role collaborates with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations and Supply Chain to implement and monitor quality processes.

The candidate will contribute to document control, change control, training management, CAPA activities, audit

Qualifications

• 2-5 years of experience in Quality Assurance, Regulatory Compliance, or related functions within a regulated industry.
• Medical Device industry experience preferred.
• Experience working in FDA-regulated and/or ISO 13485 environments preferred.
• Experience with electronic Quality Management Systems (eQMS), SAP, ETQ, ComplianceWire, or similar systems preferred.
• Experience supporting NC/CAPA, Change Control, Audit Management, and Document Control processes preferred.
• Strong understanding of FDA 21 CFR Part 820/QMSR, ISO 13485, MDSAP, and related quality system requirements.

Responsibilities

• Prepare and maintain monthly and quarterly metrics, dashboards, trend analyses, and performance reports to support business objectives and regulatory requirements.
• Coordinate and support Quality Management System Review (QSMR) activities, including data collection, metric analysis, presentation preparation, and tracking of action items.
• Facilitate and support Nonconformance (NC), Corrective and Preventive Action (CAPA), and Change Control processes, including investigations, root cause analysis, action tracking, and effectiveness verification.
• Support the administration, maintenance, and monitoring of the Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, company procedures, and applicable regulatory requirements.
• Administer document control and records management activities, including document review, approval, release, revision, retention, archival, and lifecycle management within electronic systems.
• Assist with internal audits, external audits, supplier audits, and regulatory inspections, including audit preparation, response coordination, remediation activities, and closure of findings.
• Analyze quality system data and trends to identify compliance risks, systemic issues, and opportunities for continuous improvement.
• Support inspection readiness and ongoing compliance monitoring programs to maintain a state of audit readiness.
• Collaborate with cross-functional teams including Quality, Regulatory Affairs, Engineering, Manufacturing, Operations, R&D, Supply Chain, Service, and IT to ensure effective implementation and continuous improvement of QMS processes.
• Participate in quality system enhancement, process harmonization, digital transformation, and operational excellence initiatives.
• Perform additional duties and special projects as assigned in support of Quality Systems, Compliance, and Quality Assurance operations.

Skills

Quality Assurance

Regulatory Compliance

eQMS

CAPA

Audits

Document Control

Change Control

Project Management

FDA Part 820

Cross-functional

Education

Bachelor's degree in science/engineering/business

Tools

eQMS

SAP

ETQ

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) ensuring compliance with FDA QMSR, ISO 13485, and company policies. This role collaborates with Quality, Regulatory Affairs, Manufacturing, Engineering, Operations and Supply Chain to implement and monitor quality processes.

The candidate will contribute to document control, change control, training management, CAPA activities, audit