Director of Quality
About the role
The Director of 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
- 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.
- PARTNER WITH OPERATIONS TO ENSURE PRODUCTION AND PROCESS CONTROLS, PROCESS VALIDATION, MANUFACTURING QUALITY, AND RELEASE ACTIVITIES MEET REGULATORY AND PRODUCT REQUIREMENTS.
- 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.
- ENSURES POLICIES, PROCEDURES, AND DEPARTMENTAL RESPONSIBILITIES ALIGN WITH COMPANY STRATEGY AND REGULATORY EXPECTATIONS.
Qualifications
- 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.
Skills
- 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.
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. Full-time 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
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. Full-time 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
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. Full-time 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
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. Full-time 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
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. Full-time 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
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. Full-time 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
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. Full-time 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
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. Full-time 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