ISO & QMS Auditor - 9001/13485 Specialist

foxconnggroup; San Jose (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Hon Hai seeks an ISO Associate in San Jose, CA to support the company's QMS with a focus on ISO 9001 and ISO 13485 compliance. You will conduct internal audits, manage controlled documents, and ensure procedures are current and effectively implemented.

Role is full-time with potential for permanent placement; requires 2–3 years of internal ISO audit experience, English proficiency, and a collaborative, detail-oriented mindset.

Qualifications

• 2–3 years of experience conducting ISO 9001 and 13485 internal audits.
• Experience implementing ISO management system documentation.
• Bachelor's degree in a related field preferred.

Responsibilities

• Support implementation and maintenance of the company's ISO management system.
• Assist with preparation for ISO certification, surveillance, and recertification audits.
• Coordinate documentation and evidence for internal, customer, registrar, and regulatory audits.
• Maintain audit records, findings, corrective actions, and follow-up documentation.
• Assist departments in preparing responses to audit findings and tracking corrective actions to completion.
• Monitor compliance with applicable ISO requirements and company procedures.
• Support continuous improvement of the QMS and related processes.

Skills

ISO 9001 audits

ISO 13485 audits

Documentation control

Attention to detail

Strong communication

English proficiency

Mandarin a plus

Education

Bachelor's degree

Related field (Business/Engineering/Manufacturing)

Job description

Hon Hai seeks an ISO Associate in San Jose, CA to support the company's QMS with a focus on ISO 9001 and ISO 13485 compliance. You will conduct internal audits, manage controlled documents, and ensure procedures are current and effectively implemented.

Role is full-time with potential for permanent placement; requires 2–3 years of internal ISO audit experience, English proficiency, and a collaborative, detail-oriented mindset.