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.
Job Qualifications
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.
