ISO Associate

San JoseOn-siteFull-time

AI Summary

Supports, maintains and improves the company's ISO 9001 and ISO 13485 quality management system, conducting internal audits, managing controlled documents and records, and coordinating audit evidence and corrective actions.

About this role

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.

Skills

CAPAChange ControlContinuous ImprovementCorrective And Preventive ActionDocument ControlInternal AuditingISO 13485ISO 9001ISO Certification AuditsMicrosoft OfficeNonconformance ManagementRisk Management