Quality Documentation Control Specialist

ARCH; Elmhurst (IL); On-site; USD 35,817 - 41,328; Full time

Job summary

ARCH in Elmhurst, IL seeks a detail‑oriented quality documentation specialist to maintain the QCBD file system and oversee related training. You will handle document approvals, releases, archivals, and changes to Quality System Procedures, ensuring ISO 13485 and FDA 21 CFR 820 compliance.

The role supports production and other departments, with data entry into EPICOR and audit readiness. You should have an associate degree or equivalent with 2–3 years in medical device manufacturing or document

Qualifications

• Associate degree in a technical discipline is strongly preferred or equivalent.
• 2–3 years of experience in medical device manufacturing or document management.
• 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 21 CFR 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.
• Performs device history record review and data entry as needed.
• Provides document support for internal and external audits.
• May educate and instruct plant personnel in recommended quality control testing and documentation practices.
• Assists other departments with ad-hoc projects and serves as a back up per business needs.
• Other duties as assigned.

Skills

QCBD management

Training coordination

Data entry

Regulatory familiarity

Attention to detail

Education

Associate degree preferred

Experience in medical device manufacturing

Tools

EPICOR

Job description

ARCH in Elmhurst, IL seeks a detail‑oriented quality documentation specialist to maintain the QCBD file system and oversee related training. You will handle document approvals, releases, archivals, and changes to Quality System Procedures, ensuring ISO 13485 and FDA 21 CFR 820 compliance.

The role supports production and other departments, with data entry into EPICOR and audit readiness. You should have an associate degree or equivalent with 2–3 years in medical device manufacturing or document