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.

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.