Quality Assurance Specialist

Efficient Auditing; Chicago (IL); On-site; USD 65,000 - 95,000; Full time

Job summary

Efficient Auditing in Chicago seeks a Quality Assurance Specialist to maintain the QMS aligned with ISO 9001 and ISO 13485. You will manage document control, support internal audits, CAPA, and regulatory compliance to drive operational excellence.

This role collaborates across departments, maintains training records, supports risk management, tracks metrics, and prepares management reports. The ideal candidate will have a Bachelor’s degree and 1–3 years of quality experience, with strong

Qualifications

• 1-3 years of experience in Quality Assurance in a regulated environment.
• Knowledge of ISO 9001 and ISO 13485 requirements.
• Experience with internal audits, CAPA, and process improvements.
• Strong documentation and record-keeping abilities.

Responsibilities

• Manage and maintain document control processes, ensuring all quality documents, SOPs, and records are updated, approved, and accessible.
• Coordinate and participate in internal audits, prepare audit reports, track findings, and support corrective actions.
• Oversee the Corrective and Preventive Action (CAPA) system, including logging issues, performing root cause analysis, tracking actions, and verifying closure.
• Monitor compliance with ISO standards by performing routine QMS reviews and supporting regulatory inspections when required.
• Assist in maintaining training records and ensuring employees are up to date on QMS requirements.
• Support risk management activities, process improvements, and quality-related initiatives across departments.
• Prepare quality metrics and reports for management review and help drive continuous improvement activities.
• Work collaboratively with cross-functional teams to ensure alignment with quality goals and regulatory guidelines.

Skills

Auditing

Document control

CAPA

Regulatory compliance

Analytical thinking

Communication

Education

Bachelor's degree in Quality, Engineering, Life Sciences, or related field

Tools

QMS software

Job description

The Quality Assurance Specialist will play a key role in supporting and maintaining the organization's Quality Management System (QMS) in accordance with ISO 9001 and ISO 13485 standards. This role ensures that all quality processes are effectively implemented, controlled, and continuously improved to maintain regulatory compliance and support operational excellence.

Key Responsibilities

• Manage and maintain document control processes, ensuring all quality documents, SOPs, and records are updated, approved, and accessible.
• Coordinate and participate in internal audits, prepare audit reports, track findings, and support corrective actions.
• Oversee the Corrective and Preventive Action (CAPA) system, including logging issues, performing root cause analysis, tracking actions, and verifying closure.
• Monitor compliance with ISO standards by performing routine QMS reviews and supporting regulatory inspections when required.
• Assist in maintaining training records and ensuring employees are up to date on QMS requirements.
• Support risk management activities, process improvements, and quality-related initiatives across departments.
• Prepare quality metrics and reports for management review and help drive continuous improvement activities.
• Work collaboratively with cross-functional teams to ensure alignment with quality goals and regulatory guidelines.

Qualifications

• Bachelor's degree in Quality, Engineering, Life Sciences, or a related field.
• 1-3 years of experience in Quality Assurance, preferably in a manufacturing, medical device, or regulated environment.
• Knowledge of ISO 9001 and/or ISO 13485 QMS requirements.
• Strong understanding of document control, internal auditing, CAPA processes, and compliance procedures.
• Excellent organizational, communication, and analytical skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Detail-oriented with strong problem-solving and root cause analysis abilities.

Preferred Skills

• Internal Auditor Certification (ISO 9001 or ISO 13485).
• Experience using QMS software or electronic document management systems.
• Familiarity with FDA or other regulatory requirements.