Quality Documentation & Compliance Specialist

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

Job summary

Life Spine in Huntley, IL, is seeking a Document Control Specialist to maintain, create, and modify documents ensuring compliance across all departments. This role supports training, auditing, and compliance activities within a medical device environment.

The specialist will manage document workflows, maintain Design History files, and support QA audits while coordinating with QA/RA teams. A Bachelor’s degree with quality experience is required.

Qualifications

• Bachelor’s degree with at least 2 years in a quality environment.
• Familiar with mechanical drawings, blueprint reading, statistics, and sampling.
• Experience with medical device Quality System Regulations and ISO standards.
• Experience with 510(k) and CE is preferred.

Responsibilities

• Manage and move approved documents to the controlled drive.
• Ensure appropriate signatures on all controlled documents for files.
• Log and file engineering change orders.
• Create new part numbers in the log and ERP system.
• Create UDI and keep updated in the GUDID.
• Create and maintain Product Labels.
• Perform regular document audits for accuracy and relevance.
• Scan and maintain Design History files.
• Maintain RA/QA Procedural Training.
• Participate and conduct regular quality audits.
• Maintain Distributor portal.
• All other duties as assigned.

Skills

Quality orientation

Attention to detail

Interpersonal communication

Team collaboration

Problem analysis

Manufacturing knowledge

Education

Bachelor's degree in quality or related field

Job description

Life Spine in Huntley, IL, is seeking a Document Control Specialist to maintain, create, and modify documents ensuring compliance across all departments. This role supports training, auditing, and compliance activities within a medical device environment.

The specialist will manage document workflows, maintain Design History files, and support QA audits while coordinating with QA/RA teams. A Bachelor’s degree with quality experience is required.