Job DescriptionAbout the RoleThe 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 ResponsibilitiesQuality Engineering & Continuous ImprovementLead 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 ManagementSupport 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 OversightVerify 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 & TrainingSupport 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.QualificationsEducationBachelors degree in Engineering, Quality, Life Sciences, or a related technical fieldHigh School Diploma or GED with equivalent progressive experience in regulated manufacturingExperience2+ years of quality engineering experience in a manufacturing environment5+ years of progressive experience in a regulated manufacturing environmentExperience working independently in production-driven environmentsTechnical SkillsWorking 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 toolsAbility to read and interpret technical drawings, blueprints, SOPs, and regulatory documentationStrong computer skills, including quality systems and data analysis toolsCertifications (Preferred)Six Sigma Green Belt or Black BeltAudit support experience (FDA, notified body, or customer audits)Soft SkillsStrong attention to detail and accuracyExcellent problem-solving and analytical skillsAbility to manage multiple priorities in a dynamic manufacturing environmentClear written and verbal communication across technical and non-technical audiencesCollaborative mindset with strong cross-functional engagement skillsStandards & Regulations Commonly Applied (Preferred)FDA 21 CFR Part 820 (QSR), including:820.30 Design Controls820.70 Production and Process Controls820.75 Process Validation820.90 Nonconforming Product820.100 Corrective and Preventive Action (CAPA)ISO 13485 Medical device quality management systemsISO 11135 Ethylene Oxide (EO) sterilizationISO 11137 Radiation sterilizationISO 17665 Moist heat (steam) sterilizationISO 14644 Cleanrooms and controlled environmentsWhy Is This a Great OpportunityWhy 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