Quality Engineer - Molding / Medical Devices

Location: Libertyville, IL

Work Arrangement: Onsite

Experience: 5–7 Years

Job Overview: We are seeking an experienced Quality Engineer with strong expertise in molding processes, quality engineering, and medical device manufacturing. The ideal candidate will have hands-on experience with molding operations, quality testing, PFMEA, Design of Experiments (DOE), process characterization, continuous improvement, and problem solving. Experience working within a highly regulated medical device manufacturing environment and familiarity with ISO 13485 quality standards is highly preferred.

Key Responsibilities: Support setup and operation of molding processing equipment. Perform and support quality testing of molded products. Apply PFMEA methodologies to molding and manufacturing processes. Conduct Design of Experiments (DOE) and process characterization activities. Support process validation, test runs, and production trials. Analyze quality and process data to identify yield and process-related issues. Prepare quality records, reports, charts, and graphs for technical review and presentations. Drive continuous improvement, root-cause analysis, and corrective problem-solving initiatives. Support yield improvement and process optimization activities. Provide technical assistance to process development and manufacturing engineering teams. Support new product and process development activities. Work with cross-functional teams to resolve quality and manufacturing issues. Interface with customers and support customer quality-related activities when required. Ensure manufacturing and quality activities align with applicable medical-device quality standards.

Required Skills: 5–7 years of relevant Quality Engineering experience. Hands-on experience with molding/injection molding processes Experience with molded/plastic components and manufacturing operations. Strong understanding of PFMEA Experience with Design of Experiments (DOE) Process characterization and process improvement experience. Quality testing and inspection experience. Root-cause analysis and structured problem-solving skills. Experience with production yield improvement. Experience in medical device manufacturing or another highly regulated manufacturing environment. Knowledge of ISO 13485 and medical-device quality systems. Ability to analyze quality/process data and prepare technical reports, charts, and graphs. Strong written and verbal communication skills. Ability to work effectively with manufacturing, process development, engineering, and quality teams. Preferred Experience FDA-regulated manufacturing environments. Process validation and production qualification. New product introduction (NPI). Process development support. Customer-facing quality engineering. Quality documentation and technical reporting. High-volume manufacturing environments. Experience with continuous improvement methodologies. Education Bachelor's degree in Engineering or a related discipline such as: Mechanical Engineering Manufacturing Engineering Industrial Engineering Plastics/Polymer Engineering Quality Engineering Related Engineering field