Quality System Specialist
$75k - $120.75kJohnson & Johnson
Johnson & Johnson seeks a Quality System Specialist in Milpitas, California to administer and improve the Quality Management System, ensuring compliance with FDA regulations and ISO standards. The role involves supporting document control, change management, audits, and cross-functional quality initiatives.
Responsibilities
- Prepare and maintain quality metrics, dashboards, trend analyses, and performance reports
- Coordinate Quality Management System Review activities and support nonconformance and CAPA processes
- Administer document control, records management, and lifecycle management in electronic systems
- Assist with internal, external, supplier audits and regulatory inspections including remediation
- Collaborate cross-functionally to implement and continuously improve QMS processes
Requirements
- Bachelor's degree in scientific, engineering, business, or related field
- 2-5 years quality assurance, regulatory compliance, or related experience in regulated industry
- Medical device industry experience preferred
- Knowledge of FDA 21 CFR Part 820/QMSR and ISO 13485 standards
- Experience with eQMS platforms, Agile PLM, SAP, ETQ, or ComplianceWire
- Proficiency in CAPA, Change Control, Document Control, and audit processes
- Strong project management, analytical, and interpersonal skills
Vacancy posted 13 days ago
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