Quality Engineer II

Job Purpose Support and maintain compliance of the medical device Quality Management System (QMS), strategic quality initiatives, and cross-functional quality projects. Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle. Maintain a strong working knowledge of core QMS elements, applicable standards, customer requirements, and global regulatory expectations. Essential Duties and Responsibilities Assist or lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement. Serve as the Quality lead for assigned customer accounts and product groups, including support for customer complaints, nonconformances, CAPAs, customer communications, external audits, and related quality activities. Responsible for supporting sterilization and environmental monitoring systems, including routine sterilization validations, dose audits, and related documentation. Act as a quality engineering representative on new product development or design transfer projects, ensuring compliance with design control and risk management requirements. Develop and implement risk management strategies in accordance with ISO 14971 and maintain risk files throughout product lifecycle. Provide input on process validation and sterilization validation strategies, including complex or novel technologies. Perform, schedule, and support internal, supplier, customer, and regulatory audits, and actively support external audits, including FDA, ISO, MDSAP. Drive standardization and continuous improvement in QMS elements such as CAPA, complaint handling, supplier management, metrology, calibration and document control. Use statistical tools (e.g., SPC, DOE, MSA, QC Calc) and Lean Six Sigma methodologies to identify trends, reduce defects, and improve product quality and process stability. Prepare, review, and approve technical documentation, including engineering change orders, validation protocols and reports, inspection plans, risk assessments, investigation reports, and other quality records as required. Actively participate in Value Stream Teams as a functional Quality representative, supporting first-pass yield improvement, scrap reduction, customer complaint reduction, process improvement, and overall product quality performance. Support customer complaint and nonconformance investigations, including data collection, root cause analysis, corrective and preventive action planning, implementation, effectiveness verification, and timely closure. Support quality engineering activities, including Measurement System Analysis, Test Method Validation, process validation, IQ/OQ/PQ execution, inspection method development, and cross-functional project deliverables. Program, operate, and support vision-based measurement systems such as MicroVu, Keyence, or equivalent systems to establish accurate, efficient, and repeatable measurement processes. Maintain a strong understanding of assigned customer product lines, manufacturing processes, inspection requirements, and quality risks to help minimize scrap, defects, and customer complaints. Stay abreast of changes in regulatory requirements and lead implementation of necessary updates to the QMS. Performs all other duties as assigned. Uphold SPG and Dupont vision and core values. Competencies Regulatory & Industry Leadership – Good understanding and knowledge of FDA, ISO, EU MDR, and MDSAP requirements. Acts as an internal authority and resource. Strategic Problem Solving – Leads complex problem-solving initiatives using advanced tools (8D, DMAIC, FMEA, DOE). Systems Thinking – Understands how individual QMS elements connect; capable of driving systemic improvements across the organization. Cross-functional Influence – Demonstrated ability to influence without authority and lead diverse teams toward quality goals. Mentorship & Coaching – Provides technical and professional development to less experienced engineers and team members. Audit Readiness & Response – Leads internal audits and prepares organization for external audits (e.g., FDA, Notified Body, customers). Innovation & Continuous Improvement – Drives proactive improvements to products, processes, and systems using Lean and Six Sigma methodologies. Risk-based Decision Making – Makes quality decisions by weighing compliance, business impact, and patient safety. Qualifications Required Bachelor’s or master’s degree in engineering, Science, or a related technical discipline with a minimum of 5 years of relevant experience; At least 5 years of experience in the medical device industry or a regulated manufacturing environment with increasing responsibility. Strong working knowledge of FDA QSR/QMSR expectations, ISO 13485:2016, ISO 14971, and applicable global regulatory requirements. Demonstrated experience supporting or leading audits, validation activities, CAPAs, investigations, and cross-functional quality initiatives. Strong understanding of design controls, DHF, DMR, technical files, risk management, and quality planning for new product development and design transfer. Proficient in statistical analysis, root cause analysis, corrective and preventive actions, and quality engineering tools such as 8D, 5 Whys, FMEA, MSA, SPC, and process capability. Ability to communicate effectively and influence across multiple levels of the organization. Skilled in managing multiple priorities in a fast-paced, regulated environment. Proficient with Microsoft Office tools, including Word, Excel, PowerPoint, Outlook, and SharePoint. Ability to generate reports, analyze quality data, and use basic statistical or SPC tools to support quality decisions. Ability to understand and comply with company safety, quality, and regulatory requirements. Responsible for understanding and complying with all SPG and DuPont safety policies, quality procedures, and applicable company requirements. Preferred Lean Six Sigma Black Belt or Green Belt certification. ISO 13485 Lead Auditor certification. Regulatory compliance experience with FDA, EU MDR, and MDSAP. Experience implementing or optimizing eQMS platforms. Experience in team leadership, mentoring, or informal management roles. Experience with vision-based measurement systems such as MicroVu, Keyence, or similar equipment. Experience with Power BI or other data analytics and reporting tools. Experience supporting EtO sterilization, environmental monitoring, routine sterilization validation, and dose audit activities. Knowledge of applicable EtO sterilization standards, including ANSI/AAMI/ISO 11135 and related guidance. Working Conditions Combination of office, cleanroom, and manufacturing environments. Occasional travel (up to 10%) for audits, supplier visits, or professional development. #J-18808-Ljbffr