Quality Engineer

Quality Engineer

Location: Arlington Heights, IL

Reports to: Quality Engineering Manager

Job Summary

The Quality Engineer is responsible for maintaining and improving quality engineering processes, systems, and standards across the organization. This role plays a key part in ensuring product quality, regulatory compliance, and continuous improvement initiatives.

Key Responsibilities

• Develop and implement inspection, testing, and evaluation methods to ensure product quality and reliability
• Design sampling procedures and create documentation for recording, analyzing, and reporting quality data
• Establish and manage processes for disposition of nonconforming materials, including cost impact assessment
• Lead and support product testing activities, including data collection and analysis related to materials, processes, and product performance
• Create training materials and conduct training sessions on quality systems and procedures
• Partner with Product Engineers and Quality Program Managers to support customer-related quality issues
• Ensure accuracy, integrity, and availability of quality data; compile and report on quality metrics
• Initiate, track, and drive corrective actions (CAPAs) to completion
• Support internal and external quality audits, including preparation and follow-up activities
• Develop, implement, and maintain quality standards for manufacturing processes and finished products
• Design and improve methods for evaluating product and equipment precision and accuracy
• Investigate quality issues, including returned products, and recommend corrective actions
• Establish programs to evaluate production and measurement equipment performance
• Approve product, process, and equipment qualifications
• Serve as a liaison with regulatory agencies as needed

Qualifications

• Bachelor’s degree in Engineering or a related field (or equivalent experience)
• Minimum of 6 years of experience in quality engineering
• At least 3 years of experience in the medical device, pharmaceutical, or biotechnology industry
• Wet lab experience is needed (Pharma, Med Device, Life Science, Health Care.)
• Strong knowledge of ISO 13485 standards
• Experience with quality systems and processes such as CAPA, SCAR, and NCMR
• Familiarity with FDA and ISO regulatory requirements (certifications preferred)

What We Offer

• Comprehensive medical, dental, and vision insurance
• Life insurance coverage
• Short-term and long-term disability benefits
• 401(k) with company match
• Paid vacation and sick time
• Tuition reimbursement

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.