Quality Assurance Specialist
Job in
Chicago, Cook County, Illinois, 60290, USA
Listed on 2026-10-08
Listing for:
Efficient Auditing
Full Time
position Listed on 2026-10-08
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
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.
- 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.
- Internal Auditor Certification (ISO 9001 or ISO 13485).
- Experience using QMS software or electronic document management systems.
- Familiarity with FDA or other regulatory requirements.
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