Quality System Specialist

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

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 where 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, Operations and 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.
• 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.

Qualifications

Education

A minimum of a bachelors or equivalent University degree is required with a focus in scientific, engineering, business, or related discipline preferred. Equivalent combination of education and relevant experience may be considered.

Skills & Capabilities

• 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), Agile PLM, SAP, ETQ, ComplianceWire, or similar systems preferred.
• Experience supporting NC/ CAPA, Change Control, Audit Management, and Document Control processes preferred.
• Working knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, 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 skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Strong analytical and problem-solving capabilities.
• Strong written, verbal, and presentation skills.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Ability to work independently and effectively within cross-functional teams.
• Strong attention to detail and commitment to compliance.
• Excellent interpersonal skills with the ability to influence and collaborate across all organizational levels.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$75,000.00 - $120,750.00

Additional Description For Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits