Document Control Coordinator

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

• 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
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.