Quality System Specialist

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

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.

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.

Equal Opportunity Statement

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.

Pay & Benefits

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)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.

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