Maintains and improves the Quality Management System with emphasis on ISO 9001 and ISO 13485 compliance. Manages controlled documents, records, part numbers, revisions, archives, and release packages. Conducts and supports internal, customer, registrar, and regulatory audits; maintains findings and corrective actions; and helps departments complete audit responses. Supports certification audits, QMS implementation, compliance monitoring, and continuous improvement across manufacturing operations.
Job Title: ISO / Document Control Specialist
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: 1 to 2 years of experience in Document Control. Familiarity with Agile and
document management systems.
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:
Document Control & QMS Administration
Preferred Qualifications
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.
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: 1 to 2 years of experience in Document Control. Familiarity with Agile and
document management systems.
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.
Document Control & QMS Administration
- Managing the logging, reproducing, distributing, storing, retrieving, and updating of electronic and hardcopy versions of documents such as BOM, AVL, and ECO.
- Ensures that document release packages are accurate, complete, and current.
- Ensure documents are maintained and controlled.
- Responsible for controlling and issuing part numbers for newly created parts or documents and tracking the industry, revision levels, and status through the life of the parts/documents.
- Scan, image, organize and maintain documents.
- Adhere to the company’s document lifecycle procedures, and archive inactive records in accordance with the records retention schedule.
- 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.
- Experience with electronic document management systems or QMS software.
- 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.
- Familiarity with engineering change orders (ECO/ECN) and manufacturing process documentation.
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.
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What you need to know about the Los Angeles Tech Scene
Los Angeles is a global leader in entertainment, so it’s no surprise that many of the biggest players in streaming, digital media and game development call the city home. But the city boasts plenty of non-entertainment innovation as well, with tech companies spanning verticals like AI, fintech, e-commerce and biotech. With major universities like Caltech, UCLA, USC and the nearby UC Irvine, the city has a steady supply of top-flight tech and engineering talent — not counting the graduates flocking to Los Angeles from across the world to enjoy its beaches, culture and year-round temperate climate.
Key Facts About Los Angeles Tech
- Number of Tech Workers: 375,800; 5.5% of overall workforce (2024 CompTIA survey)
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- Key Industries: Artificial intelligence, adtech, media, software, game development
- Funding Landscape: $11.6 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Strong Ventures, Fifth Wall, Upfront Ventures, Mucker Capital, Kittyhawk Ventures
- Research Centers and Universities: California Institute of Technology, UCLA, University of Southern California, UC Irvine, Pepperdine, California Institute for Immunology and Immunotherapy, Center for Quantum Science and Engineering
