Director of Quality

Reports to:

Chief Development and Compliance Officer

Job Title:

Director of Quality

Department:
Quality

Work Location:

In-person (Eden Prairie, MN)

Pay Range: $155,000-$170,000

Position Type and Expected Hours of Work:
Full-Time, Monday-Friday, 40 hours/week

Elucent Medical is a medical device company focused on developing surgical navigation technologies, particularly for cancer surgery, to improve patient outcomes through precision and efficacy. The company's solutions are designed to transform traditional surgical instruments into “smart” tools, enhancing surgical precision and patient outcomes.

The Director, Quality owns two integrated areas of accountability:
Elucent's Quality Management System (QMS) and product quality performance. This role provides strategic direction and hands‑on leadership to ensure Elucent's products are safe, reliable, effective, and compliant across the full product lifecycle.

Responsibilities include QMS implementation and continuous improvement in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, as well as product quality leadership across design assurance, manufacturing quality, supplier quality, complaint handling, CAPA, and post‑market surveillance. The Director identifies and mitigates quality and compliance risks, leads quality planning for company growth, and maintains audit and inspection readiness.

As a strategic partner to executive leadership, the Director builds a high‑performing quality organization and embeds quality practices into R&D, Operations, Supply Chain, Regulatory, and Commercial workflows.

• Recruit, hire, and train quality team members across quality systems and product quality functions.
• Mentor and develop staff, providing career growth opportunities and building depth within the function.
• Manage daily priorities, workload, and performance for the quality team.
• Provide timely feedback, coaching, and performance evaluations.

• Owns product quality outcomes and metrics across design and development, manufacturing, distribution, and post‑market surveillance.
• Oversees and/or leads design assurance with R&D, including design controls, design reviews, V&V planning and execution, design transfer, risk management, and technical documentation compliance.
• Partners with Operations to ensure production and process controls, process validation, manufacturing quality, and release activities meet regulatory and product requirements.
• Oversees supplier qualification, monitoring, performance management, and supplier audit programs to ensure requirements are met from sourced materials through finished goods.
• Uses customer feedback, complaints, nonconformances, CAPA outcomes, and post‑market surveillance data to identify trends and drive systemic improvements.
• Ensures customer, regulatory, and product quality requirements are defined, verified, and maintained across design, manufacturing, suppliers, and service operations.

• Owns and continuously improves the QMS in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, including MDSAP and EU MDR as appropriate.
• Serves as Quality Management Representative, maintains inspection readiness, and leads FDA, Notified Body, customer, supplier, and internal audits.
• Oversees CAPA, nonconforming materials, complaint handling, document control, change control, supplier quality system processes, and internal audits.
• Ensures risk management processes are effectively embedded throughout the product lifecycle.
• Leads eQMS enhancements, process optimization, and quality system continuous improvement initiatives.
• Ensures policies, procedures, and departmental responsibilities align with company strategy and regulatory expectations.

• Defines, analyzes, and reports QMS and product quality metrics to support data‑driven decisions and executive‑level visibility.
• Provides training, tools, and cross‑functional guidance to strengthen quality ownership and compliance across the organization.