Medical Device Document Control & Compliance Specialist

Life Spine; Huntley (IL); On-site; USD 55,000 - 75,000; Full time

Job summary

Life Spine is seeking a Document Control Specialist to maintain, create, and modify documents for training, auditing, and compliance across all departments. The role centers on document management, system and process documentation, and file storage (electronic and physical).

You will log and file engineering change orders, create new part numbers, maintain UDI in the GUDID, create and maintain product labels, and participate in regular quality audits and documentation control activities within a

Qualifications

• Bachelor's degree; minimum two years in a quality environment.
• Familiarity with mechanical drawings and blueprint reading.
• Experience with medical device Quality System Regulations (QSR) and ISO standards; 510(k) and CE knowledge preferred.

Responsibilities

• Manage and move approved documents to the controlled drive.
• Ensure appropriate signatures on all controlled documents.

Skills

Quality orientation

Interpersonal skills

Communication skills

Team collaboration

Problem solving

Education

Bachelor's degree in quality/engineering or related field

Tools

ERP system

GUDID

Job description

Life Spine is seeking a Document Control Specialist to maintain, create, and modify documents for training, auditing, and compliance across all departments. The role centers on document management, system and process documentation, and file storage (electronic and physical).

You will log and file engineering change orders, create new part numbers, maintain UDI in the GUDID, create and maintain product labels, and participate in regular quality audits and documentation control activities within a