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.