Document Control Specialist - Medical Devices (1st Shift)

ARCH; Elmhurst (IL); On-site; USD 36,000 - 41,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

ARCH is seeking a detail-oriented Quality Documentation Specialist to maintain the QCBD system and oversee related training within our Quality Management framework. The role involves document approval, release, archival, and obsolescence processes, as well as updating product DMRs and staff training records.

You will enter data into EPICOR, support internal and external audits, and back up for ad-hoc projects across departments. 1st shift, $26-$30/hr, Equal Opportunity Employer.

Qualifications

• Associate degree in technical discipline preferred or two to three years in medical device document management/training.
• Experience in medical device manufacturing or document management systems.
• Regulatory knowledge in ISO 13485 and FDA 21 CFR 820.
• High accuracy typing and extreme attention to detail.

Responsibilities

• Maintain, update and manage QCBD document file system.
• Organize and oversee QCBD training related to the Quality Management system.
• Execute document approval, release, archival, and obsolescence per the quality system.
• Modify and document changes to Quality System Procedures.
• Support audits with document control and compliance.
• Submit and process change orders under ISO 13485 and FDA 21 CFR Part 820.
• Enter data into EPICOR and assist with data entry/trend analysis.
• Back up for ad-hoc projects and assist other departments as needed.

Skills

Attention to detail

Typing accuracy

Regulatory knowledge

Document management

Education

Associate degree in technical discipline

Equivalent education/experience

Tools

EPICOR

Job description

ARCH is seeking a detail-oriented Quality Documentation Specialist to maintain the QCBD system and oversee related training within our Quality Management framework. The role involves document approval, release, archival, and obsolescence processes, as well as updating product DMRs and staff training records.

You will enter data into EPICOR, support internal and external audits, and back up for ad-hoc projects across departments. 1st shift, $26-$30/hr, Equal Opportunity Employer.