Document Control Coordinator

Lead Dog Recruiting; Irvine (CA); Hybride; USD 60 000 - 80 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Attention to detail

Multi-project management

Formation

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

Outils

QCBD (ERP/PLM)

Description du poste

Lead Dog Recruiting is assisting a medical device manufacturer in its search for a Document Control Coordinator. This is a hybrid role based in Irvine. Once you're fully trained, you'll work from home on Mondays and Fridays.

In this role, you will support the Quality Management System by administering the change control process, maintaining document and part revisions, and making sure product structures and labeling records stay accurate, current, and compliant with applicable regulatory requirements (such as ISO 13485 and FDA QMSR).

Requirements

• Formal training in ISO 13485 or Good Documentation Practices (such as ASQ 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