Quality Engineer

Job Description About the Role The Quality Engineer serves as a key quality and regulatory resource within an FDA-regulated manufacturing environment. This role partners closely with manufacturing, inspection, and customer-facing teams to ensure products consistently meet internal specifications, customer requirements, and applicable regulatory standards. The Quality Engineer leads continuous improvement initiatives, supports product and process lifecycle activities, and ensures compliance with FDA Quality System Regulations, sterilization standards, and cleanroom requirements. Key Responsibilities Quality Engineering & Continuous Improvement Lead continuous improvement initiatives within assigned manufacturing areas using data-driven analysis. Perform root cause analysis and implement corrective and preventive actions (CAPA) in alignment with FDA expectations. Review, investigate, and disposition nonconforming product in accordance with established quality procedures. Product & Process Lifecycle Management Support the full product lifecycle from introduction through sustained production, including design transfer, process qualification, validation, and ongoing process monitoring. Develop and maintain control plans, qualification protocols (IQ/OQ/PQ), and risk-based quality documentation to minimize scrap and prevent customer returns. Ensure change management activities are properly evaluated, documented, and approved throughout the product lifecycle. Regulatory Compliance, Sterilization & Cleanroom Oversight Verify that manufacturing instructions, SOPs, and quality records comply with customer requirements and FDA regulations, including 21 CFR Part 820. Support sterilization and cleanroom-controlled manufacturing processes in compliance with FDA and applicable ISO standards. Ensure validation activities meet FDA expectations for special processes, including sterilization. Cross-Functional Support & Training Support quality inspectors and technicians by developing, maintaining, and explaining procedures, work instructions, and quality standards. Partner with manufacturing, production, and customer service teams to resolve quality issues and maintain regulatory alignment. Qualifications Education Bachelors degree in Engineering, Quality, Life Sciences, or a related technical field High School Diploma or GED with equivalent progressive experience in regulated manufacturing Experience 2+ years of quality engineering experience in a manufacturing environment 5+ years of progressive experience in a regulated manufacturing environment Experience working independently in production-driven environments Technical Skills Working knowledge of FDA Quality System Regulations (21 CFR Part 820) Experience supporting product and process validation activities (IQ/OQ/PQ) Proficiency with SPC, statistical analysis, and quality data tools Ability to read and interpret technical drawings, blueprints, SOPs, and regulatory documentation Strong computer skills, including quality systems and data analysis tools Certifications (Preferred) Six Sigma Green Belt or Black Belt Audit support experience (FDA, notified body, or customer audits) Soft Skills Strong attention to detail and accuracy Excellent problem-solving and analytical skills Ability to manage multiple priorities in a dynamic manufacturing environment Clear written and verbal communication across technical and non-technical audiences Collaborative mindset with strong cross-functional engagement skills Standards & Regulations Commonly Applied (Preferred) FDA 21 CFR Part 820 (QSR), including: 820.30 Design Controls 820.70 Production and Process Controls 820.75 Process Validation 820.90 Nonconforming Product 820.100 Corrective and Preventive Action (CAPA) ISO 13485 Medical device quality management systems ISO 11135 Ethylene Oxide (EO) sterilization ISO 11137 Radiation sterilization ISO 17665 Moist heat (steam) sterilization ISO 14644 Cleanrooms and controlled environments Why Is This a Great Opportunity Why Join Us? Join a regulated manufacturing organization where quality and compliance are core to operational success. Play a critical role in product lifecycle management, sterilization oversight, and continuous improvement. Work cross-functionally with engineering, manufacturing, and customer teams in a hands-on environment. Opportunity to deepen expertise in FDA, ISO, and cleanroom-controlled manufacturing processes. #J-18808-Ljbffr NPAworldwide