Quality Manager Location:

Glenview, IL Salary:

$80,000-$90,000 per year

Job Type:

Full-time Position Summary A manufacturing company specializing in condition-monitoring and product-indicator solutions is seeking a hands-on Quality Manager to lead its Quality Management System (QMS) and ensure compliance with FDA regulations and

ISO 13485

standards. Key Responsibilities Maintain and improve the Quality Management System (QMS). Ensure compliance with

FDA 21 CFR

Part 820 and

ISO 13485.

Lead internal, customer, ISO, and FDA audits. Manage CAPA, customer complaints, nonconformances, and root cause analysis. Oversee risk assessments and FMEA activities. Drive continuous improvement and collaborate with cross-functional teams. Required Qualifications Bachelor's degree in Engineering, Chemistry, Science, Quality, or a related field; equivalent experience may be considered. Minimum of 5 years of experience in quality management or a similar role. Strong knowledge of

ISO 13485, FDA

regulations, and quality management systems. Hands-on experience with audits, CAPA, and root cause analysis. Experience in regulated manufacturing; medical device experience strongly preferred. Strong analytical, problem-solving, and leadership skills.

Preferred:

Lean/Six Sigma, ERP systems, and QMS software experience. Spanish bilingual skills are a plus. Compensation & Benefits $80,000-$90,000 annual base salary, depending on experience. Medical, dental, and vision insurance. 401(k), life insurance, and annual bonus. Paid holidays and PTO. Interested candidates are encouraged to apply!

Pay:

$80,000.00 - $90,000.00 per year

Benefits:

401(k) Dental insurance Life insurance

Education:

Bachelor's (Preferred)

Experience:

ISO 13485

5 years (Preferred) FDA regulations applicable to medical devices: 5 years (Preferred) Quality management: 5 years (Preferred)

Work Location:

In person