ISO / Document Control Specialist
Full-time
Foxconn Industrial Internet
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. F amiliarity 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
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. F amiliarity 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.
- 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.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the ISO / Document Control Specialist in San Jose, CA vacancy
- ...Experis is seeking a QMS Document Control Administrator in Santa Clara, CA to support the Quality Assurance team. This role focuses on managing... ..., strong attention to detail, and familiarity with ISO 9001/13485. This is a 12-month contract with competitive hourly...SuggestedHourly payContract work
Experis
Santa Clara, CA22 hours ago $33 per hour
...currently assisting a local customer in their search for QMS & Document Control Specialist positions in Santa Clara, CA . This is a great... ...Working knowledge of Quality Management Systems (QMS) and ISO 9001 and/or ISO 13485 standards. ~ Experience with PLM systems...SuggestedHourly payTemporary workWork at officeLocal areaMonday to FridayShift workAdecco US, Inc.
Santa Clara, CA2 days ago$28 - $40 per hour
...support our Quality Assurance, Quality Control, document control, inspection, and manufacturing... ...Clerk to experienced Quality Technicians/Specialists with hands-on inspection and medical-... ...broader commercialization under an FDA- and ISO-regulated quality system....SuggestedGalaxy Therapeutics
Milpitas, CA4 days ago$45 - $55 per hour
...you find a job that works for you. We’re hiring a Senior Document Control Specialist for an opportunity in Santa Clara, California . With us,... ...regulated industry. An understanding of FDA 21 CFR 820, ISO 13485 documentation requirements, especially pertaining to...SuggestedHourly payContract workTemporary workWork experience placementWork at officeLocal areaRemote work3 days per weekKelly Services
Santa Clara, CA1 day ago$55 - $60 per hour
...55.00/hr - $60.00/hr W2 Position Onsite Role in Sunnyvale, CA Document Control Analyst Summary The Document Control Analyst will support product... ...and experience working in regulated environments (i.e. ISO 13485) and sufficient knowledge and experience to be able to operate...SuggestedFull timeFlexible hoursEPITEC
Sunnyvale, CA2 days ago$33 - $35 per hour
...leading organization in the manufacturing sector, is seeking a QMS Document Control Administrator to join their team. As a QMS Document Control... .... Working knowledge of QMS principles and standards (ISO 9001 and/or ISO 13485 preferred). Experience with PLM systems...Hourly payWeekly payContract workTemporary workFlexible hoursExperis
Santa Clara, CA3 days ago$77k - $118k
...Document Control SpecialistAt Springtide, a division of IPS, we listen, understand, and lean into complex challenges to unlock new solutions... ...to do more.We are looking for a talented Document Control Specialist to join our dedicated team at our project site in Santa...For contractorsFor subcontractorNight shiftSpringtide Project Services
Santa Clara, CA3 days ago- ...Document Control SpecialistJoin our client as a document control specialist in Santa Clara, CA. A global leader dedicated to making the world healthier, cleaner, and safer! Bring your degree and 2-5 years of QMS and change management experience to support document control...
Randstad
Santa Clara, CA3 days ago $117k - $143k
...and shape your story with Mott MacDonald, where everyone has the opportunity to be brilliant . We are currently seeking a Document Controls Specialist to support the Anderson Dam Seismic Retrofit Project (ADSRP), one of California's significant dam safety and water...Contract workTemporary workFor contractorsWork at officeFlexible hours3 days per weekMott MacDonald
San Jose, CA1 day ago$33 - $35 per hour
job summary: Join Our Client as a Document Control Specialist in Santa Clara, CA a global leader dedicated to making the world healthier, cleaner, and safer! Bring your degree and 2-5 years of QMS and change management experience to support document control in a regulated...Hourly payContract workTemporary workWork experience placementLocal areaSanta Clara, CA9 days ago$68k - $85k
Thanks for your interest in Oklo! We are searching for a Document Control and Records Specialist to join our team. Position Description The Document Control and Records Specialist is responsible for the day-to-day administration of Electronic Document Management System...Remote workFlexible hours- Responsibilities Manage controlled documents throughout their lifecycle by coordinating reviews and processing document approval, release, revision, supersession, cancellation, and obsolescence while ensuring document integrity and revision control. Process incoming records...Remote work
- Jobtailor in Santa Clara, CA, is seeking a skilled Document Control/Records Specialist to manage controlled documents and records through their lifecycle, ensuring integrity, revisions, and compliant workflows. The role requires 5+ years in a regulated environment, experience...Remote job
- Oklo is seeking a Document Control and Records Specialist to manage EDMS workflows and oversee document control and records management in a regulated environment. You will coordinate reviews, approvals, and revisions while maintaining metadata and ensuring compliant filing...Remote job
- A leading imaging technology company located in Santa Clara, CA, is seeking a proactive Document Control Administrator. This role is pivotal in improving operational efficiency while delivering top-notch customer service. Ideal candidates will possess strong Microsoft...Work at office
- We are seeking a detail-oriented Training and Document Control Specialist to build and maintain robust training programs and document control systems... ...Perform internal audits and support external audits (ISO 9001, ISO 14001, customer, and regulatory) for training effectiveness...Monday to FridayShift work
- Springtide Project Services is seeking a Document Control Specialist for our project site in Santa Clara, California. You will manage the storage and transmission of project documents produced by Springtide, its clients, vendors, subcontractors, and consultants. Qualified...For subcontractor
$26 - $34 per hour
...Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Elevait Solutions As an Document Control Specialist/Engineering Services Analyst, you’ll ensure smooth documentation and change control processes for engineering and...Contract workElevait Solutions
Mountain View, CA3 days ago- ...Document Control SpecialistThe Document Control Specialist will be responsible for managing, organizing, tracking, and maintaining technical, quality, and project documentation throughout its full lifecycle. This individual will support document intake, review, approval...
Insight Global
Mountain View, CA1 day ago - Quality System Document Control Administrator Location: Santa Clara, CA 95054 (Onsite) | Job Type: Contract About the Role Join a dynamic... ...- Practical knowledge of QMS principles; familiarity with ISO 9001 or ISO 13485 guidelines - Experience with Product...Contract workWork at office
Indotronix International Corporation
Santa Clara, CA4 days ago $35 - $45 per hour
Position: Document Control Administrator Pay Rate: $35-$45 per hour Location: Santa Clara, CA Description We are seeking a proactive, detail-oriented Document Control Administrator to join our team in Santa Clara, CA. This role is essential to maintaining efficient...Hourly payWork at office- Job Title: Document Control Associate San Jose, CA About the job: FULL-TIME/TEMPORARY (POSSIBILITY FOR PERMANENT) JOB FUNCTION: As a Document Control Associate you will be responsible for managing company documents while also ensuring their accuracy, quality, and integrity...Permanent employmentFull timeTemporary workLocal area
- ...support our Quality Assurance, Quality Control, document control, inspection, and manufacturing... ...Clerk to experienced Quality Technicians/Specialists with hands-on inspection and medical-... ...experience. This position emphasizes FDA- and ISO-regulated quality practices. #J-18808-...
- ...Documentation Specialist Specifically focused in developing the training program and knowledge base for the workflow. May help in developing documentation for large workforce management implementation with PEX with the ability to create documentation/visualization...
ClifyX
San Jose, CA4 days ago - ...Documentation Specialist Title: Documentation Specialist Location: Remote Duration: 08/01/2020 to 01/31/2022 Pay Rate: $35/hr on w2 all inclusive Client: State of Louisiana Job Description: Documentation Specialist Document system functionality, system...Remote work
Omega Solutions
Santa Clara, CA4 days ago - YO IT Consulting is seeking a Document Reviewer to apply expertise in training AI systems. The role involves reviewing structured and unstructured data to ensure accuracy, adhering to strict guidelines and protecting sensitive information. Successful candidates will have...Remote job
- ...Job Description Job Description Document Reviewer Job Type: Contractor Location: Remote Job Overview We are seeking detail-oriented Document Reviewers to support a project focused on data quality, privacy, and integrity. You will review transformed documents...Remote jobFor contractors
YO AI Labs
San Jose, CA7 days ago - ...important we are able to transition the access assets to the new nodes with no disruption to access.Responsibilities:Build out documentation (website).Collecting and analyzing team graph data sheets to ensure seamless transition of assets from one team node to another....
$22 - $28 per hour
...customer service, production, and leadership by helping keep orders, documentation, and communication organized and accurate. It is a great... ...through Build your skills in ERP systems, documentation control, and manufacturing workflows Join a culture that emphasizes...Hourly payFull timeTemporary workWork at officeLocal areaMonday to FridayDynamic Office & Accounting Solutions
Santa Clara, CA3 days ago- ...Counselors and Senior Guidance Counselors. The position prepares and tracks enlistment and medical-processing records, performs document quality control, maintains applicant files and suspense actions, and coordinates with military, civilian, recruiting, and medical...Civilian ContractorFull timeContract workFor contractorsWork at officeLocal areaMonday to Friday
Summit Technologies
Mountain View, CA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to ISO / Document Control Specialist. Be the first to apply!
Related searches
- document analyst San Jose, CA
- document manager San Jose, CA
- document processing San Jose, CA
- document technician San Jose, CA
- document writer San Jose, CA
- document scanning San Jose, CA
- document San Jose, CA
- engineering document control San Jose, CA
- document control coordinator San Jose, CA
- paralegal document review San Jose, CA