Quality Manager

Title : Quality Manager

Location : Elgin, IL

Hire Type : Direct Hire

Pay : $115k-$125k / yr.

The Quality Manager is responsible for overseeing the Quality Assurance function for a manufacturing organization producing precision components for medical devices. This role ensures compliance with AS9100, ISO 9001, and applicable regulatory requirements while driving continuous improvement initiatives to maintain product integrity and customer satisfaction. The Quality Manager partners closely with Materials, Engineering, Production, and Quality teams to ensure accuracy and effectiveness of quality programs.

Job Duties :

Maintain and continuously improve the Quality Management System (QMS) to ensure compliance with AS9100, ISO 9001, and applicable regulatory requirements

Lead internal, supplier, and external audits (registrars and regulatory bodies)

Ensure proper document control, record retention, and configuration management

Oversee CAPA, NCRs, root cause analysis, risk management, and traceability requirements

Manage incoming, in-process, and final inspections; approve quality plans and validation protocols

Ensure calibration and maintenance of inspection and measuring equipment

Lead, mentor, and develop quality engineers, inspectors, and technicians

Implement Lean, Six Sigma, and continuous improvement initiatives to reduce defects

Establish quality metrics, dashboards, and performance trend reporting

Manage customer complaints and ensure timely corrective actions

Qualifications :

Bachelor’s degree in Engineering, Quality Management, or related field

4–10 years of quality leadership experience in a manufacturing environment

Strong knowledge of AS9100, ISO 9001, and FDA requirements

Experience with audits, CAPA, risk management, and process validation

Familiarity with ERP and QMS software systems

Lean manufacturing and Six Sigma experience required

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.