Director/Senior Director of Quality Assurance

Location: San Diego, CA (Onsite / Hybrid)

Industry: Medical Technology – Electrophysiology

Company Stage: Private, Early Commercial

Reports to: CEO

About the Role

We are a privately held, early-commercial medical technology company in the electrophysiology space, delivering innovative solutions to improve the diagnosis and treatment of cardiac arrhythmias. With FDA 510(k) clearance and CE Mark achieved, we are transitioning from development into commercial scale. We are seeking a Director/Senior Director of Quality Assurance to lead and evolve our Quality function to support global commercialization, manufacturing scale-up, and post-market excellence.

This role will be a key leadership position responsible for maintaining regulatory compliance, strengthening the Quality Management System, and ensuring product quality across the product lifecycle in a highly regulated, fast-growing environment. The level of this role will be determined based on the candidate’s experience, scope of prior leadership, and demonstrated impact.

Key Responsibilities

Key Responsibilities include, but are not limited to:

Quality Management System (QMS) Leadership

• Lead and continuously improve the Quality Management System in compliance with FDA QMSR (21 CFR 820), ISO 13485, and EU MDR requirements
• Ensure QMS scalability to support increased production, global distribution, and future product introductions
• Drive quality culture, accountability, and continuous improvement across the organization
• Act as Vektor Medical’s Management Representative
• Act as Vektor Medical’s Person Responsible for Regulatory Compliance (PRRC)

Quality Management System Compliance

• Manage Document Control System (Qualio) and training program, ensuring that the processes needed for QMS are effectively established, implemented and maintained
• Oversee complaint handling, MDR/Vigilance reporting, trending, and post-market surveillance activities for U.S. and EU markets
• Ensure timely, compliant execution of CAPA, root cause analysis, and effectiveness checks
• Partner with Clinical, Regulatory, and Medical Affairs on field safety actions and performance monitoring

Manufacturing & Supplier Quality

• Lead manufacturing quality activities including incoming inspection, nonconformance management, change control, and process validation
• Establish and manage supplier quality agreements, audits, and performance monitoring
• Responsible for finished goods inspections and overall quality of components in accordance with the company’s standards

Audit & Inspection Readiness

• Lead internal audits and support FDA inspections, Notified Body audits, and customer audits
• Serve as the primary Quality representative during regulatory inspections and commercial audits
• Ensure audit readiness and effective, timely responses to findings

Design Change & Lifecycle Management

• Ensure quality oversight of design changes, sustaining engineering, and product enhancements post-clearance
• Maintain risk management files (ISO 14971) and ensure alignment with real-world use and post-market data
• Support labeling, IFU updates, and change assessments for global markets

Leadership & Cross-Functional Collaboration

• Build, mentor, and lead the Quality Assurance team as commercial operations scale
• Partner closely with Operations, R&D, Product Development and Commercial teams
• Provide quality updates and risk assessments to executive leadership

Qualifications

Required

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline
• 10+ years of Quality Assurance experience in medical devices
• 5+ years in a Quality leadership role
• Hands-on experience supporting early commercial products with 510(k) clearance and CE Mark
• Strong working knowledge of FDA QSR, ISO 13485, EU MDR, ISO 27001
• Experience leading regulatory inspections and Notified Body audits

Preferred

• Startup or high-growth MedTech company experience
• Direct experience with electrophysiology, cardiovascular, or Class II/III medical devices
• Experience scaling manufacturing and supplier quality post-launch
• ASQ certification (CQA, CQE)
• Experience supporting international market expansion
• Experience with Qualio or other electronic QMS platform(s)

Key Competencies

• Hands-on leader with strong execution focus
• Sound judgment in balancing compliance, risk, and commercial speed
• Strong communication and influence across technical and non-technical teams
• Detail-oriented with a systems-level perspective
• Comfortable operating in ambiguity and change