Quality Engineer

Quality Engineer at Sterling Engineering Quality Engineer at Sterling Engineering in Prospect Heights, Illinois Posted in 4 days ago.

Type:

full-time

Job Description:

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.