Quality Engineer III

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 Education Experience Knowledge Skills and Abilities

Required:

• Bachelors Degree in Engineering (Biomedical Mechanical Industrial or related field); Masters preferred.
• 58 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.