Quality System Specialist

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment that each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Milpitas, California, United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Quality System Specialist! This position can be located in Milpitas, CA.

Position Summary:

The Quality System Specialist is responsible for supporting the administration, maintenance, monitoring, and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA Quality System Regulations (21 CFR Part 820/QMSR), ISO 13485, company policies, and other applicable regulatory requirements. This role supports document control, change control, training management, CAPA activities, quality system remediation projects, compliance monitoring, quality metrics reporting, Quality Management Review (QMR) activities, and audit readiness initiatives.

The individual works cross‑functionally with Quality, Regulatory Affairs, Manufacturing, Engineering, Operationsand Supply Chain to ensure that quality system processes are effectively implemented, maintained, monitored, and continuously improved.

Adheres to environmental policy, procedures, and supports department environmental objectives.

Key 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.
• Assistwith 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 andongoingcompliance monitoring programs to maintain a state of audit readiness.
• Collaborate with cross‑functional teams including Quality, Regulatory Affairs, Engineering, Manufacturing, Operationsand R&D, SupplyChain, Service, andIT to ensure effective implementation and continuous improvement of QMS processes.
• Participatein quality system enhancement, process harmonization, digital transformation, and operational excellence initiatives.
• Perform additional duties and special projects as assignedinsupportof QualitySystems,Compliance, andQuality Assurance operations.

Qualifications:

Education:

Aminimumof a bachelors or equivalentUniversitydegreeisrequiredwithfocusinscientific, engineering, business, or relateddisciplinespreferred. Equivalentcombinationof‑educational–replace‐Progression etc....

Skills & Capabilities:

• 2-5 years of experience in Quality Assurance, Regulatory Compliance, or related functions within regulated industry.
• Medical Device industry experience preferred.
• Experience working in FDA-regulated and/or ISO13485 environments preferred.
• ExperiencewitheQMS, Agile PLM, SAP, ETQ, ComplianceWire, or similar systems preferred.
• ExperiencesupportingNC/ CAPA, ChangeControl, Audit Management, and Document Control processes preferred.
• Working knowledge of FDA 21CFRPart 820/QMSR, ISO13485, MDSAP, and related quality system requirements.
• Understanding of CAPA, Change Control, Document Control, Training, Risk Management, and Audit processes.
• Strong project management, organization, and prioritization