Director of Quality – Medical Device

About the role

Elucent Medical seeks a seasoned Director of Quality to lead its Quality Management System (QMS) and product quality performance. This senior leader will ensure that all medical device products are safe, reliable, effective, and compliant throughout their lifecycle.

Key responsibilities

• Implement, maintain, and continuously improve the QMS in line with 21 CFR Part 820, ISO 13485, ISO 14971, and global standards.
• Provide strategic and hands‑on leadership for design assurance, manufacturing quality, supplier quality, complaint handling, CAPA, and post‑market surveillance.
• Identify and mitigate quality and compliance risks, lead quality planning for growth, and keep the organization audit‑ready.
• Build and mentor a high‑performing quality team, overseeing recruitment, training, performance management, and career development.
• Embed quality practices across R&D, Operations, Supply Chain, Regulatory, and Commercial functions.

Required profile

• Proven experience leading quality functions in the medical device industry.
• Deep knowledge of FDA regulations, ISO standards, and risk management processes.
• Strong track record of driving continuous improvement and managing cross‑functional teams.
• Excellent communication and stakeholder management skills.

Required skills

• 21 CFR Part 820 compliance
• ISO 13485 implementation
• ISO 14971 risk management
• Design controls and design assurance
• CAPA management
• Post‑market surveillance
• Supplier qualification and audit programs

What we offer

• Competitive salary range $155,000‑$170,000 per year
• Full‑time, on‑site role in Eden Prairie, MN
• Opportunity to shape quality strategy in an innovative medical‑device company