Document Control Specialist – ISO/FDA Compliance

Arch-Medical-Solutions; Elmhurst (IL); On-site; USD 36,000 - 41,000; Full time

Job summary

Arch-Medical-Solutions in Elmhurst, IL is seeking a document control specialist to maintain the QCBD system, manage training, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820. You will handle change orders, product DMRs, and audits, while supporting cross-department needs.

The role requires accuracy, strong data entry skills, and experience with medical device regulatory requirements. 1st shift, hourly pay range applies, and Arch supports equal opportunity employment.

Qualifications

• Associate degree in applicable technical discipline is strongly preferred or equivalent.
• Two to three years of experience in medical device manufacturing industry and/or document management systems and/or training.
• Basic regulatory knowledge in medical regulations.
• Accuracy of typing skills and extreme attention to detail are required.
• Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations.

Responsibilities

• Maintains, updates and manages QCBD document file system.
• Organizes and oversees QCBD training related to the Quality Management system.
• Executes document approval, release, archival, and obsolescence, per the quality system.
• Modifies and documents changes to Quality System Procedures.
• Functions as an information source for production and other departments when critical quality documentation issues arise.
• Submits and processes change orders under ISO 13485 and FDA 21 CFR Part 820.
• Monitors device history records process to meet ISO 13485 and FDA 21 CFR Part 820.
• May perform data entry and trend analysis and initiate negative trend corrective actions.
• Works with management in all company areas to effectively resolve document errors/omissions.
• Updates and maintains product DMRs.
• Maintains staff training records and ensure QCBD training is current.
• Accurately enters data into EPICOR.
• Provides document support for internal and external audits as needed.
• Educates plant personnel in recommended quality control testing and documentation practices.
• Assists other departments with ad-hoc projects and serves as backup per business needs.
• Other duties as assigned.

Skills

Typing accuracy

Attention to detail

Data entry

Trend analysis

Regulatory knowledge

Quality systems knowledge

Education

Associate degree in applicable technical discipline

Tools

EPICOR

Job description

Arch-Medical-Solutions in Elmhurst, IL is seeking a document control specialist to maintain the QCBD system, manage training, and ensure compliance with ISO 13485 and FDA 21 CFR Part 820. You will handle change orders, product DMRs, and audits, while supporting cross-department needs.

The role requires accuracy, strong data entry skills, and experience with medical device regulatory requirements. 1st shift, hourly pay range applies, and Arch supports equal opportunity employment.