Director of Quality

Job Title:
Director of Quality

Department:
Quality

Reports to:
Chief Development and Compliance Officer

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

Job Summary:
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.

Supervisory Responsibilities:

• 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.

Job Responsibilities:

Product Quality and Design Assurance:

• 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.

Quality Systems & Compliance

• 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.

Quality Leadership & Culture

• 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.

Qualifications

Education and Experience:

• Bachelor's degree in life science, engineering, or a related technical field required; advanced degree preferred.
• 10+ years of progressive quality experience in the FDA-regulated medical device industry, with demonstrated leadership across both QMS and product quality functions.
• 8+ years of experience 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; familiarity with statistical methods including trend analysis.
• Proficiency with modern eQMS tools and quality system software.
• Hands-on leadership style with the ability to operate strategically while maintaining operational oversight of QMS and product quality activities.
• Strong organizational, project management, prioritization, and follow-through skills.

Required Skills/Abilities:

Leadership & Strategy:

• Provides strategic leadership for QMS and product quality functions, ensuring systems, processes, and product outcomes are integrated and mutually reinforcing.
• Serves as the organizational subject matter expert for quality system requirements, product quality standards, and risk-based quality decisions.
• Develops and mentors high-performing quality and compliance teams to support company growth and market expansion.
• Aligns R&D, Operations, Supply Chain, Regulatory, and Commercial stakeholders around quality compliance and product quality performance throughout the lifecycle.

Communication

• Demonstrates excellent written and verbal communication skills, including regulatory and audit responses and executive-level quality metrics presentations.
• Communicates quality system requirements and product quality expectations clearly and effectively across all levels of the organization.
• Provides training, coaching, and guidance to build a culture of compliance, quality ownership, and continuous improvement

Physical Requirements / Work Conditions:

• Travel: 10%
• 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

Elucent Medical Benefits, Culture and Work Environment
At Elucent Medical, we prioritize our employees' well-being by providing comprehensive benefits including comprehensive health insurance, a generous retirement savings plan with company matching, flexible work arrangements, generous paid time off, and ongoing professional development opportunities, ensuring a fulfilling and balanced work life.

Fulltime Employees are provided:
401(k)
401(k) matching (4%)
Dental insurance
Health insurance
Vision insurance
Paid Holidays
Paid Vacation Days
Paid Sick Days
Short Term Disability
Long Term Disability
Life Insurance
Pet Insurance
Employee Assistance Programs

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.