Document Control Coordinator

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

• Maintains, updates and manages QCBD (Quality Collaboration By Design) 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 DMR’s.
• Maintains staff training records and working with supervision ensuring that all QCBD training is to current requirements.
• Accurately enters data into EPICOR.
• Provides document support for internal and external audits, as needed.
• May educate and instruct plant personnel in recommended quality control testing and equipment methods and acceptable documentation practices.
• Assists other departments with ad-hoc projects and serves as a back up per business needs.
• Other duties as assigned.

Qualifications

• Associate degree in applicable technical discipline is strongly preferred or equivalent,
• or two (2) to three (3) years of experience in medical device manufacturing industry and/or document management systems and/or training,
• or equivalent combination of education and experience.
• 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.

Shifts Available: 1st shift

Salary Range: $26.00 - $30.00/hr based on experience

ARCH is an Equal Opportunity Employer who wholeheartedly supports diversity in the workplace as basic premise for business success. We do not discriminate on a basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer
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