Document Control 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 focused on providing innovative solutions to address spinal pathology from the occiput to the sacrum. Our comprehensive product portfolio that centers around fusion and minimally invasive surgeries is driven by patient and surgeon needs. We are dedicated to improving the quality of life for patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards and the most technologically advanced manufacturing platforms. We are looking for responsive, customer centric innovators to provide solutions for spinal pathology.

The Document Control Specialist is responsible to maintain, create, and modify all documents in a compliant and efficient manner for training, auditing, and compliance purposes across all departments. The primary purpose of this position is to perform and serve as the primary document and records coordinator who will manage the workflow of internal and external documents including document management, system and process documentation, and document storage (electronic and physical).

Duties and Responsibilities also include:

• 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

Qualifications: Bachelor’s degree with a minimum of two years working in a quality environment. Familiar with mechanical drawings, blueprint reading, statistics, and sampling, preferred. Experience and knowledge of medical device Quality System Regulations and ISO Standards. Experience with 510(k) and CE preferred.

Essential experience and skills:

• Quality orientation and high attention to detail.
• Excellent interpersonal and communication skills.
• Experience working with high performance teams.
• Problem analysis and problem resolution skills.
• General knowledge of manufacturing processes.

Physical Demands: Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Must be able to sit for long periods of time.