Director of Quality
$155,000–$170,000 year
On-site · Eden Prairie, Minnesota, United States
Job Summary
Director of Quality oversees Elucent Medical’s Quality Management System and product quality across the full lifecycle. Leads QMS implementation and continuous improvement per 21 CFR Part 820, ISO 13485, ISO 14971; directs design assurance, manufacturing quality, supplier quality, CAPA, complaint handling, and post-market surveillance; partners with executive leadership to embed quality into R&D, Operations, Regulatory, and Commercial workflows; builds a high-performing quality organization; recruits and mentors quality staff; owns product quality outcomes, design controls, risk management, supplier qualification, audits, and regulatory readiness; ensures compliance with applicable global standards and readiness for FDA/Notified Body/audits; requires heavy leadership, strategic planning, data-driven decision making, and strong communication; limited travel (~10%).
Required Qualifications
- Bachelor's degree in life science, engineering, or related technical field required
Desired Qualifications
- Advanced degree in related field (preferred)
- Experience leading QMS and product quality functions in FDA-regulated medical devices
- Strong regulatory knowledge: 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR
- Proven leadership in design control, risk management, CAPA, supplier quality, post-market surveillance
- Experience with FDA, Notified Body, customer, and supplier audits
- Strong analytical, data-driven decision-making skills; proficiency with eQMS tools
- Travel readiness (approx. 10%)
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