Document Control Specialist

Currier; San Jose (CA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

PTO

401K match

Job summary

Currier is seeking a Document Control Specialist to manage and maintain documentation in compliance with ISO 13485:2016. You will handle quality plans, production documents, inspection reports, calibration records, and supplier documentation within IQMS.

Responsibilities include updating quality plans, ensuring timely uploads of supplier documents, verifying batch records, COC verification, and maintaining traceability of certificates.

Qualifications

• High school diploma or equivalent required.
• Excellent reading of drawings and ability to translate into work instructions.
• Strong attention to detail and organizational skills.
• Experience in document control in a manufacturing environment preferred.
• ISO 13485:2016 knowledge or exposure is a plus.
• Proficiency with IQMS or similar ERP systems is desirable.
• Must read, write, and communicate in English.

Responsibilities

• Manage and update quality plans, in-process documents, and drawings in the IQMS system.
• Ensure accurate upload of supplier-related documents to IQMS.
• Review and save last-shot paperwork from production runs.
• Verify batch production records for completeness and accuracy.
• Perform COC verification and authorization.
• Ensure proper storage and traceability of material certificates.
• Verify and save inspection reports for compliance with company standards.
• Coordinate MRB activities and calibration record updates as required.

Skills

Attention to detail

Cross-department collaboration

English communication

Documentation interpretation

Education

High school diploma or equivalent

Tools

Microsoft Office Suite

Job description

The Document Control Specialist is responsible for managing and maintaining the integrity of documentation and record-keeping in compliance with ISO 13485:2016 standards. This role involves handling quality plans, production documentation, inspection reports, calibration activities, and supplier-related records, ensuring that all documentation is accurate, up-to-date, and readily accessible within the IQMS system.Duties:

• Manage and update quality plans, in-process documents, and drawings in the IQMS system
• Ensure accurate and timely upload of supplier-related documents to the IQMS system
• Review and save last-shot paperwork from production runs
• Verify batch production records for completeness and accuracy
• Perform COC (Certificate of Conformance) verification and authorization
• Ensure proper storage and traceability of material certificates
• Verify and save inspection reports for compliance with company standards
• Handle supplier-related documentation, ensuring timely uploads and updates in the IQMS system
• Maintain compliance with ISO 13485:2016 requirements and company quality standards
• Identify opportunities for process improvement in document control and record management systems

When Required:

• Participate in Material Review Board (MRB) activities, including quarantine, meeting coordination, disposition, and record-keeping
• Coordinate calibration activities for tools and ensure up-to-date calibration records

Requirements:
Skills and Requirements:

• High school diploma or equivalent required;
• Ability to read part drawings and translate dimensional and cosmetic requirements from a drawing into written work instructions for machine operators.
• One to three years of experience in document control, preferably in a manufacturing environment
• Experience working in an ISO 13485:2016-certified company is a plus
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook)
• Strong attention to detail and organizational skills
• Ability to work collaboratively across departments and with external suppliers
• Familiarity with quality management processes
• Must be able to read, write, and verbally communicate in English

Benefits:
Standard Health, Dental, Vision Benefits.
Generous PTO.
401K Match.