ISO 13485 Document Control Specialist – Quality & Compliance

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

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.