Quality Engineer III

## Description**Job Purpose:**Serve as a senior-level Quality Engineer with leadership responsibilities in medical device QMS compliance, strategic quality initiatives, and cross-functional project execution. Drive continuous improvement in product quality, regulatory compliance, and risk management across the product lifecycle. Act as a subject matter expert (SME) in core QMS elements and global regulatory standards.---**ESSENTIAL DUTIES:*** Lead large-scale or cross-functional quality projects involving product lifecycle management, validation, CAPA, audit readiness, risk management, or supplier quality improvement.* Act as a quality lead 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 expert-level input on process validation and sterilization validation strategies, including complex or novel technologies.* Lead internal and supplier audits and actively support external audits (FDA, ISO, MDSAP) as quality system SME.* Drive standardization and continuous improvement in QMS elements such as CAPA, complaint handling, supplier management, and document control.* Serve as a mentor and technical resource for junior engineers and cross-functional stakeholders.* Use statistical tools (e.g., SPC, DOE, MSA) and Lean Six Sigma methodologies to identify trends, reduce defects, and improve product quality and process stability.* Develop and present quality performance reports to leadership; make data-driven recommendations for improvement.* Review and approve technical documentation including engineering change orders, validation protocols, inspection plans, and risk assessments.* Actively participate in Value Stream Teams as a functional member, engaged in improving first pass yield, scrap reduction, process improvements.* 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** – Expert 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**QUALIFICATIONS Education, Experience, Knowledge, Skills and Abilities****Required:*** Bachelor’s Degree in Engineering (Biomedical, Mechanical, Industrial, or related field); Master’s preferred.* 5–8 years of experience in the medical device industry with increasing responsibility.* Expert knowledge of FDA QSR, ISO 13485:2016, ISO 14971, and global regulatory expectations.* Demonstrated experience leading audits, validation activities, and cross-functional quality initiatives.* Strong understanding of design controls, DHF/DMR/Tech Files, and quality planning for new product development.* Proficient in statistical analysis, RCA and corrective actions using problem solving (e.g., 8D, 5W), and other quality engineering tools.* Ability to communicate and influence across multiple levels of the organization.* Skilled in managing multiple priorities in a fast-paced, regulated environment.* Responsible for understanding and complying with all SPG and Dupont safety policies and procedures**Preferred:*** Lean Six Sigma Black Belt certification.* ISO 13485 Lead Auditor certified* Regulatory compliance experience with FDA, EU MDR, and MDSAP.* Experience implementing or optimizing eQMS platforms.* Experience in team leadership, mentoring, or informal management roles.**Working Conditions:**Combination of office, cleanroom, and manufacturing environments. Occasional travel (up to 10%) for audits, supplier visits, or professional development.
#J-18808-Ljbffr