Quality Systems Specialist: QMS & Compliance

Johnson & Johnson MedTech

Milpitas (CA)

On-site

USD 75,000 - 121,000

Full time

4 hours ago

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Benefits offered by this job

Vacation 120 hours

Sick time 40 hours

Holiday pay

Parental Leave

Bereavement Leave

Volunteer Leave

Military Spouse Time-Off

Job summary

Johnson & Johnson is seeking a Quality System Specialist to support the Quality Management System at our Milpitas, CA site. This role collaborates with Quality, Regulatory Affairs, Manufacturing, and Supply Chain to ensure compliance with FDA QMSR and ISO 13485, and to drive continuous improvement.

Responsibilities include document control, CAPA, change control, audits, data analytics, and training management.

Qualifications

Bachelor's degree in a scientific, engineering, business, or related field.
2–5 years in Quality Assurance or regulatory compliance in a regulated industry.
Experience with FDA 21 CFR Part 820/QMSR and ISO 13485 preferred.

Responsibilities

Prepare and maintain monthly and quarterly metrics and dashboards.
Coordinate QMSR activities, data collection, and item tracking.
Lead NC/CAPA and Change Control investigations and actions.
Support QMS administration to ensure regulatory compliance.
Manage document control and records lifecycle in electronic systems.
Assist internal and external audits with response coordination.
Analyze quality data to identify compliance risks and improvements.
Support inspection readiness and ongoing compliance monitoring.
Collaborate with cross-functional teams to improve QMS processes.
Participate in quality system enhancement and digital transformation initiatives.