Onsite QMS Engineer - Audit & CAPA Leader

Universal Scientific Industrial Co., Ltd.; Milpitas (CA); On-site; USD 120,000 - 140,000; Full time

Job summary

Universal Scientific Industrial Co., Ltd. in Milpitas, CA is seeking a highly organized QMS Engineer to develop, implement, maintain, and improve the Quality Management System to ensure compliance with ISO 9001, IATF 16949, ISO 13485, and ISO 14001.

The role supports audits, CAPA, KPI monitoring, and cross-functional collaboration with engineering, manufacturing, and supply chain. This is a 100% onsite, full-time position reporting to the Quality Manager.

Qualifications

• Bachelor’s degree in Engineering or Quality Management required.
• ISO 9001 Lead Auditor certification required.
• 5+ years related experience; 3+ years in Electronic Manufacturing industry.

Responsibilities

• Develop, implement, and sustain quality management systems in alignment with ISO 9001, IATF 16949, ISO 13485, and ISO 14001 standards.
• Plan, conduct, and lead internal and external audits, including supplier audits, ensuring compliance with applicable standards and customer-specific requirements.
• Oversee the CAPA process, ensuring timely and effective resolution of non-conformances and continuous improvement.
• Ensure all QMS documentation is current, controlled, and accessible, facilitating smooth audits and compliance checks.
• Provide training to staff on quality standards, procedures, and best practices to foster a quality-centric culture.
• Monitor and analyze KPIs related to quality, driving initiatives to reduce non-conformances and improve metrics.
• Work closely with engineering, manufacturing, and supply chain to ensure quality standards are integrated across operations.
• Stay up-to-date with changes in relevant standards and regulations.

Skills

Quality management

Auditing

CAPA management

KPIs

Project management

Team collaboration

Analytical thinking

Education

Bachelor's degree in Engineering

ISO 9001 Lead Auditor

Tools

MS Office

ERP systems

PLM systems

Electronic QMS systems

Job description

Universal Scientific Industrial Co., Ltd. in Milpitas, CA is seeking a highly organized QMS Engineer to develop, implement, maintain, and improve the Quality Management System to ensure compliance with ISO 9001, IATF 16949, ISO 13485, and ISO 14001.

The role supports audits, CAPA, KPI monitoring, and cross-functional collaboration with engineering, manufacturing, and supply chain. This is a 100% onsite, full-time position reporting to the Quality Manager.