ISO Associate

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

Job Title: ISO Associate

San Jose, CA

About the job:

FULL-TIME/ TEMPORARY to PERMANENT

Job Function:

The ISO / Document Control Specialist is responsible for supporting, maintaining, and continuously improving the company's Quality Management System (QMS), with a primary focus on ISO 9001 and ISO 13485 compliance. This position will conduct internal audits, manage controlled documents and records, and ensure that management system documentation is current, accurate, and effectively implemented across the organization.

Qualifications:

Education: Bachelor's degree in business administration, Engineering, Manufacturing, or a related field preferred.

Experience: 2 to 3 years of experience independently conducting internal audits for ISO 9001 and 13485. Implementing and maintaining ISO management system documentation.

Language: English proficiency is required; Mandarin proficiency is a plus.

Skills:

• Excellent verbal and written communication skills.
• Strong attention to accuracy and detail in documentation.
• Ability to effectively present information and respond professionally to questions from managers and employees.
• Strong active listening and interpersonal skills.
• Highly detail-oriented with a commitment to accuracy and quality.
• Proficient in computer operating systems and Microsoft Office applications.
• Ability to effectively manage multiple tasks, priorities, and deadlines.
• Open-minded, approachable, and outgoing, with a positive and collaborative attitude.

Responsibilities:

ISO Compliance & Audit Support

• 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 requested during 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.

Preferred Qualifications:

• Experience in PCBA/SMT, electronics, medical devices, or other manufacturing environments.
• Experience supporting ISO certification or surveillance audits.
• Familiarity with corrective and preventive action (CAPA), nonconformance, change control, and risk management processes.
• Knowledge of CAPA, NCR, corrective/preventive action, and continuous improvement processes.

Hon Hai is an Equal Opportunity Employer (EOE). All qualified candidates will receive consideration without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or marital status in accordance with applicable federal, state and local laws.