Director of Quality - Eden Prairie, MN

Precision that changes outcomes for real patients, and a quality function you actually get to build. This is a build seat at a company growing about 75 percent, not a keep-the-lights-on role.

About Elucent Medical

Elucent Medical builds surgical guidance technology that turns standard instruments into smart tools. Our EnVisio System uses In-Body Spatial Intelligence to give surgeons real-time 3D awareness of depth, distance, and direction, so they can locate and remove a tumor with accuracy that was not possible before, at five times the depth of traditional localization. A lot of that work happens in breast cancer surgery, where our SmartClip and SmartSensor help surgeons navigate complex tissue with confidence. The result is care that is less disruptive and more effective, and it has a direct impact on the lives of the women who trust their surgeons with an outcome that matters deeply.

We are also in a period of real momentum. The company is growing quickly, around 75 percent, and expanding into new markets. That kind of growth is exciting, and it raises the bar for quality. As we scale, we need a quality function that keeps our products safe, reliable, and compliant without slowing the pace of progress.

Why This Role Matters

This is not a role where you inherit a finished system and maintain it. You will own both the Quality Management System and product quality performance, and you will shape how quality operates as the company grows. We give our leaders room to lead. You will have the autonomy to make decisions, set direction, and build the function the way it needs to be built. In return, we ask you to help create a culture where quality is not one department's job but a goal everyone shares. When R&D, Operations, Supply Chain, Regulatory, and Commercial all feel ownership over quality outcomes, the whole company moves faster and with more confidence. Building that shared ownership is a core part of the work.

The Role

The Director of Quality owns two connected areas: Elucent's Quality Management System and our product quality performance across the full product lifecycle. You will provide both strategic direction and hands-on leadership to keep our products safe, reliable, effective, and compliant, from early design through post-market surveillance. You will lead QMS implementation and continuous improvement in line with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards. You will also lead product quality across design assurance, manufacturing quality, supplier quality, complaint handling, CAPA, and post-market surveillance. Beyond the systems and metrics, you will partner with executive leadership to build a strong quality organization and embed quality practices into the workflows of every team that touches the product.

Supervisory Responsibilities

• Recruit, hire, and train quality team members across quality systems and product quality functions
• Mentor and develop staff, creating real 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

Responsibilities

Product Quality and Design Assurance

• Own product quality outcomes and metrics across design and development, manufacturing, distribution, and post-market surveillance
• Lead or oversee design assurance with R&D, including design controls, design reviews, V&V planning and execution, design transfer, risk management, and technical documentation compliance
• Partner with Operations to ensure production and process controls, process validation, manufacturing quality, and release activities meet regulatory and product requirements
• Oversee supplier qualification, monitoring, performance management, and supplier audit programs, from sourced materials through finished goods
• Use customer feedback, complaints, nonconformances, CAPA outcomes, and post-market surveillance data to spot trends and drive systemic improvements
• Ensure customer, regulatory, and product quality requirements are defined, verified, and maintained across design, manufacturing, suppliers, and service operations

Quality Systems and Compliance

• Own and continuously improve the QMS in line with 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global standards, including MDSAP and EU MDR as appropriate
• Serve as Quality Management Representative, maintain inspection readiness, and lead FDA, Notified Body, customer, supplier, and internal audits
• Oversee CAPA, nonconforming materials, complaint handling, document control, change control, supplier quality system processes, and internal audits
• Ensure risk management processes are effectively embedded throughout the product lifecycle
• Lead eQMS enhancements, process optimization, and quality system continuous improvement initiatives
• Ensure policies, procedures, and departmental responsibilities align with company strategy and regulatory expectations

Quality Leadership and Culture

• Define, analyze, and report QMS and product quality metrics to support data-driven decisions and give leadership clear visibility
• Provide the training, tools, and cross-functional guidance that strengthen quality ownership and compliance across the organization

Qualifications

Education and Experience

• Bachelor's degree in a life science, engineering, or a related technical field is required; an advanced degree is preferred
• 10 or more years of progressive quality experience in the FDA-regulated medical device industry, with demonstrated leadership across both QMS and product quality functions
• 8 or more years managing, developing, and scaling quality teams
• Expert knowledge of medical device QMS and regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global requirements
• Hands-on experience owning product quality outcomes across design assurance, supplier quality, manufacturing quality, complaint handling, CAPA, and post-market surveillance
• Experience overseeing CAPA, nonconformances, internal and external audits, change control, document control, and supplier quality programs
• Proven ability to serve as Quality Management Representative and lead FDA, Notified Body, customer, and supplier audits
• Strong analytical and data-driven decision-making skills, with familiarity in statistical methods including trend analysis
• Proficiency with modern eQMS tools and quality system software
• A hands-on leadership style, with the ability to think strategically while keeping operational oversight of QMS and product quality activities
• Strong organizational, project management, prioritization, and follow-through skills

Skills and Abilities

Leadership and Strategy

• Provide strategic leadership for QMS and product quality functions so that systems, processes, and product outcomes reinforce one another
• Serve as the organization's subject matter expert for quality system requirements, product quality standards, and risk-based quality decisions
• Develop and mentor high-performing quality and compliance teams that can support company growth and market expansion
• Align R&D, Operations, Supply Chain, Regulatory, and Commercial stakeholders around quality compliance and product quality performance throughout the lifecycle

Communication

• Communicate clearly in writing and in person, including regulatory and audit responses and executive-level quality metrics presentations
• Convey quality system requirements and product quality expectations effectively at every level of the organization
• Provide training, coaching, and guidance that build a culture of compliance, quality ownership, and continuous improvement

Physical Requirements & Work Conditions

• Travel: approximately 10 percent
• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds at times
• Office and manufacturing floor environments

Pay

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

Schedule

Monday to Friday, 40 hours/week

Benefits

• 401(k) with 4% company match
• Health, dental, and vision insurance
• Paid holidays, vacation, and sick days
• Short-term and long-term disability
• Life insurance
• Pet insurance
• Employee Assistance Programs
• Ongoing professional development