QA Manager - ISO 9001, CAPA & Supplier Quality

Astronova,-Inc.; Elk Grove Village (IL); On-site; USD 90,000 - 120,000; Full time

Job summary

Astronova, Inc. in Elk Grove Village, IL is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of quality management systems in a regulated environment.

You will drive CAPA, perform root cause analysis, manage supplier quality, and collaborate across production, regulatory, and engineering teams to ensure ISO 9001 compliance and product quality.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum 5 years of quality assurance in a regulated industry (medical devices or pharmaceuticals preferred).
• Proven expertise in quality systems management, including ISO9001 compliance.
• Experience with CAPA and root cause analysis methodologies.
• Experience managing supplier quality and conducting supplier audits.

Responsibilities

• Develop, implement, and maintain quality management systems in compliance with ISO9001 and other relevant standards.
• Lead investigations and root cause analysis for quality issues, driving corrective and preventive action plans to resolution.
• Manage supplier quality assurance activities, including audits, performance monitoring, and improvement initiatives.
• Collaborate with cross-functional teams to integrate quality processes into product development and manufacturing.
• Monitor quality metrics and prepare reports to communicate quality performance and improvement opportunities to senior management.
• Ensure regulatory compliance and prepare documentation for audits and inspections.
• Train and mentor quality assurance staff to promote a culture of quality and continuous improvement.

Skills

Quality management

CAPA

Root cause analysis

Supplier quality

Data analysis

Analytical skills

Communication skills

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Quality management software

Data analysis tools

Job description

Astronova, Inc. in Elk Grove Village, IL is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of quality management systems in a regulated environment.

You will drive CAPA, perform root cause analysis, manage supplier quality, and collaborate across production, regulatory, and engineering teams to ensure ISO 9001 compliance and product quality.