ISO 13485 Document Control Specialist - Generous PTO & 401K

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

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.