Document Control Specialist

Currier Plastics, Inc.; San Jose (CA); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health benefits

PTO

401K Match

Job summary

Currier Plastics, Inc. is seeking a Document Control Specialist to manage and maintain quality documentation in compliance with ISO 13485:2016. You will ensure documents, plans, and records are accurate, up-to-date, and accessible in the IQMS system.

Responsibilities include updating drawings and production documents, verifying batch records, performing COC verification, and maintaining traceability of certificates, while aligning with MRB activities and supplier documentation.

Qualifications

• High school diploma or equivalent.
• Read drawings and translate to work instructions.
• 1–3 years of document control in manufacturing.
• ISO 13485:2016 experience is a plus.
• Proficiency with Microsoft Office Suite.
• English communication skills.

Responsibilities

• Manage and update quality plans, in-process documents, and drawings in IQMS.
• Upload supplier-related documents to IQMS.
• Review and file last-shot paperwork from production.
• Verify batch production records for completeness.
• Perform COC verification and authorization.
• Ensure storage and traceability of material certificates.
• Verify inspection reports for compliance with standards.
• Handle supplier documentation with timely uploads.
• Maintain ISO 13485:2016 compliance and company standards.
• Identify opportunities to improve document control processes.

Skills

Read drawings

Microsoft Office

Attention to detail

Organizational skills

Cross-functional collaboration

Quality management processes

Education

High school diploma or equivalent

Tools

IQMS system

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.

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.