Hybrid Doc Control Specialist ISO 13485 | Remote

Lead Dog Recruiting; Irvine (CA); Hybrid; USD 60,000 - 80,000; Full time

Job summary

Lead Dog Recruiting is assisting a medical device manufacturer in Irvine with a Document Control Coordinator role. The hybrid position allows remote work on Mondays and Fridays after training, supporting the quality system and change control processes.

You will maintain document revisions, ensure labeling and product structures remain accurate, and help ensure regulatory compliance with ISO 13485 and FDA QMSR.

Qualifications

• Formal training in ISO 13485 or Good Documentation Practices (such as CQIA, CQPA, or CQA).
• 3+ years of experience with an ERP/PLM system (QCBD preferred).
• Ability to manage multiple projects with strong attention to detail.

Responsibilities

• Administer the change control process as part of the Quality Management System.
• Maintain document and part revisions and ensure accuracy of product structures and labeling records.

Skills

Attention to detail

Multi-project management

Education

ISO 13485 training / GDP (CQIA/CQPA/CQA)

Tools

QCBD (ERP/PLM)

Job description

Lead Dog Recruiting is assisting a medical device manufacturer in Irvine with a Document Control Coordinator role. The hybrid position allows remote work on Mondays and Fridays after training, supporting the quality system and change control processes.

You will maintain document revisions, ensure labeling and product structures remain accurate, and help ensure regulatory compliance with ISO 13485 and FDA QMSR.