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.
