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Director of Quality
Elucent Medical | Eden Prairie, MN | In-Person Leadership Role
You will not be walking into a cleanup job. You will be inheriting a strong, well-run quality system, an experienced and capable team, and a mandate to help a fast-growing medical device company scale both. If you want real ownership, executive visibility, and the chance to build something rather than just maintain it, this is that role.
About Elucent Medical
Elucent Medical designs surgical navigation technology that gives breast cancer surgeons a level of precision the field has never had before. Built on In-Body Spatial Intelligence, the company's EnVisio System, along with tools like SmartClip and SmartSensor, turns standard surgical instruments into smart, connected tools that help surgeons locate tumors and guide procedures with far greater accuracy. It is technically interesting, patient-impact work, and the company is growing quickly.
The Opportunity
The Director, Quality owns two integrated areas: Elucent's Quality Management System and product quality performance across the full lifecycle. You will provide both strategic direction and hands-on leadership, ensuring the company's products are safe, reliable, effective, and compliant, while building the kind of quality organization that scales with the business instead of slowing it down.
You will lead a team of 12 or more across quality systems, quality engineering, technicians, and design assurance, and you will report directly to the Chief Development and Compliance Officer.
REPORTS TO
Chief Development & Compliance Officer
WORK MODEL
4 days/week onsite initially
TRAVEL
~10%
TEAM SIZE
12 direct & indirect reports
Why This Role Is Worth Your Attention
STRONG FOUNDATION
You are inheriting a proven, nimble QMS that has been through two FDA inspections with no 483s, along with multiple notified-body audits and no nonconformances. The groundwork is already solid.
HIGH-CALIBER TEAM
You are stepping into an experienced group with capable leaders already in place across quality engineering, quality systems, and design assurance.
GROWTH PLATFORM
Superior technology, an expanding pipeline, and strong financing create a genuine scale-up mandate, not a turnaround.
What You Will Own
Product Quality & Design Assurance
Required
Solution-Minded. Servant-Led. Team-First.
Elucent is looking for a solution-minded quality leader , someone whose default answer is “here is how we can do this correctly,” not “no, we can’t.” A servant leader who rolls up their sleeves, models the behavior they expect, and genuinely develops the people around them. Someone pragmatic and adaptable enough to make good decisions without the deep specialist bench of a much larger company, and who values “we” over “me.”
Above all, this is a leader people trust enough to come to early, not one they learn to avoid.
Benefits
Elucent Medical provides equal employment opportunities to all employees and applicants, and prohibits discrimination or harassment of any kind based on race, color, religion, age, sex, national origin, disability, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.
Elucent Medical | Eden Prairie, MN | In-Person Leadership Role
You will not be walking into a cleanup job. You will be inheriting a strong, well-run quality system, an experienced and capable team, and a mandate to help a fast-growing medical device company scale both. If you want real ownership, executive visibility, and the chance to build something rather than just maintain it, this is that role.
About Elucent Medical
Elucent Medical designs surgical navigation technology that gives breast cancer surgeons a level of precision the field has never had before. Built on In-Body Spatial Intelligence, the company's EnVisio System, along with tools like SmartClip and SmartSensor, turns standard surgical instruments into smart, connected tools that help surgeons locate tumors and guide procedures with far greater accuracy. It is technically interesting, patient-impact work, and the company is growing quickly.
The Opportunity
The Director, Quality owns two integrated areas: Elucent's Quality Management System and product quality performance across the full lifecycle. You will provide both strategic direction and hands-on leadership, ensuring the company's products are safe, reliable, effective, and compliant, while building the kind of quality organization that scales with the business instead of slowing it down.
You will lead a team of 12 or more across quality systems, quality engineering, technicians, and design assurance, and you will report directly to the Chief Development and Compliance Officer.
REPORTS TO
Chief Development & Compliance Officer
WORK MODEL
4 days/week onsite initially
TRAVEL
~10%
TEAM SIZE
12 direct & indirect reports
Why This Role Is Worth Your Attention
STRONG FOUNDATION
You are inheriting a proven, nimble QMS that has been through two FDA inspections with no 483s, along with multiple notified-body audits and no nonconformances. The groundwork is already solid.
HIGH-CALIBER TEAM
You are stepping into an experienced group with capable leaders already in place across quality engineering, quality systems, and design assurance.
GROWTH PLATFORM
Superior technology, an expanding pipeline, and strong financing create a genuine scale-up mandate, not a turnaround.
What You Will Own
Product Quality & Design Assurance
- Own product quality outcomes and metrics across design, development, manufacturing, distribution, and post-market surveillance.
- Lead design assurance alongside R&D, including design controls, design reviews, verification and validation planning and execution, design transfer, risk management, and technical documentation.
- Partner with Operations on production and process controls, process validation, manufacturing quality, and release activities.
- Oversee supplier qualification, monitoring, performance management, and audit programs from sourced materials through finished goods.
- Turn complaints, nonconformances, CAPA outcomes, and post-market data into trends and systemic improvements, not just closed tickets.
- 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 needed.
- Serve as Quality Management Representative and lead FDA, Notified Body, customer, supplier, and internal audits.
- Oversee CAPA, nonconforming materials, complaint handling, document control, change control, and internal audit processes.
- Embed risk management throughout the product lifecycle, and lead eQMS enhancements and process improvement initiatives.
- Recruit, hire, train, mentor, and develop your team, building real depth rather than just filling seats.
- Define and report QMS and product quality metrics that support executive-level, data-driven decisions.
- Build a culture where colleagues seek Quality out early, because the answer they expect is “here is how we can do this correctly,” not “no.”
- You become the person people across the organization turn to for answers, guidance, and risk-based decisions.
- You learn the product, technology, team, and operating model quickly enough to lead credibly across R&D, Operations, Supply Chain, Regulatory, and Commercial.
- You preserve what already works while refining the processes that need to scale with rapid growth.
- You take real ownership of the function, and you have the confidence to respectfully challenge executive leadership when the data, the regulations, or patient risk call for it.
- You coach your team, delegate effectively, and build a culture where quality is seen as an enabling partner, not the sheriff.
Required
- Bachelor's degree in life science, engineering, or a related technical field; advanced degree preferred.
- 10 years of progressive quality leadership in FDA-regulated medical devices, spanning both QMS and product quality.
- 8 years managing, developing, and scaling quality teams.
- Deep hands-on experience across design assurance, manufacturing quality, supplier quality, complaint handling, CAPA, and post-market surveillance.
- Proven experience serving as Quality Management Representative and personally leading FDA and Notified Body inspections or audits.
- Meaningful experience with electro-mechanical medical devices.
- Strong analytical skills, including trend analysis, and fluency with modern eQMS tools.
- Experience with embedded software and hardware-software interaction.
- Background in small-to-mid-sized medtech, where leaders stay close to the work and operate resourcefully.
- A track record of scaling systems during growth without burying the team in unnecessary bureaucracy.
- The ability to read data and risk, then translate it into pragmatic action rather than more process.
Solution-Minded. Servant-Led. Team-First.
Elucent is looking for a solution-minded quality leader , someone whose default answer is “here is how we can do this correctly,” not “no, we can’t.” A servant leader who rolls up their sleeves, models the behavior they expect, and genuinely develops the people around them. Someone pragmatic and adaptable enough to make good decisions without the deep specialist bench of a much larger company, and who values “we” over “me.”
Above all, this is a leader people trust enough to come to early, not one they learn to avoid.
Benefits
- 401(k) with 4% company match
- Paid holidays, vacation, and sick days
- Life insurance and pet insurance
- Health, dental, and vision insurance
- Short-term and long-term disability
- Employee Assistance Program
- Full-time, Monday through Friday, 40 hours a week
- In-person in Eden Prairie, MN, with roughly 10 percent travel
- Primarily desk-based, with the ability to lift up to 25 pounds and move between office and manufacturing floor environments
Elucent Medical provides equal employment opportunities to all employees and applicants, and prohibits discrimination or harassment of any kind based on race, color, religion, age, sex, national origin, disability, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by law.