Vektor Medical, Inc. · 11 hours ago
Director of Quality Assurance
San Diego County, CA
Full-time
Hybrid
Director/Executive
$150K/yr - $210K/yr
10+ years expVektor Medical, Inc. is a privately held, early-commercial medical technology company specializing in electrophysiology. They are seeking a Director/Senior Director of Quality Assurance to lead and enhance their Quality function, ensuring regulatory compliance and product quality as they transition to commercial scale.
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Hiring Manager
Ariane Hussainy
Responsibilities
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)
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
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
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
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
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
Qualification
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)
Company
Vektor Medical, Inc.
Vektor Medical is on a mission to revolutionize arrhythmia care.
11-50 employees
H1B Sponsorship
Vektor Medical, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (1)
2022 (1)
Funding
Current Stage
Early StageTotal Funding
$28.99M2024-02-05Series A· $25M
2019-11-01Series Unknown· $3.6M
2018-07-13Seed· $0.02M
Leadership Team
Robert Krummen
Chief Executive Officer
Doug Komen
Chief Financial Officer, Board Member
Recent News
Company data provided by crunchbase