Vektor Medical, Inc.
Director of Quality Assurance
Vektor Medical, Inc., California, Missouri, United States, 65018
Base pay range
$150,000.00/yr - $210,000.00/yr
Additional compensation types Annual Bonus
Director/Senior Director of Quality Assurance
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
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)
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
Seniority level Not Applicable
Employment type Full‑time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Vektor Medical, Inc. by 2x
Inferred from the description for this job Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Get notified about new Director of Quality Assurance jobs in
San Diego County, CA .
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Additional compensation types Annual Bonus
Director/Senior Director of Quality Assurance
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
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)
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
Seniority level Not Applicable
Employment type Full‑time
Job function Quality Assurance
Industries Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Vektor Medical, Inc. by 2x
Inferred from the description for this job Medical insurance
Vision insurance
401(k)
Paid maternity leave
Paid paternity leave
Get notified about new Director of Quality Assurance jobs in
San Diego County, CA .
#J-18808-Ljbffr