Director of Quality

Visby Medical

. Lead and develop Visby’s quality organization .

Posted 10/16/2026full-timeSan Jose • California • United StatesLead💰 $200,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading quality management systems compliant with FDA QMSR and ISO 13485, while fostering a culture of continuous improvement and effective risk management throughout the product lifecycle. Proven ability to develop and manage quality teams, ensuring alignment with business objectives and successful outcomes in regulatory audits.

Highest-signal resume keywords

Quality Management System (QMS) DevelopmentFDA QMSR ComplianceISO 13485 KnowledgeTeam Leadership and DevelopmentSoftware Quality Assurance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)Risk ManagementRegulatory ComplianceQuality AuditsProcess ImprovementCross-Functional Team LeadershipSoftware VerificationCybersecurity RequirementsMolecular Infectious Disease TestingDigital Tools Implementation

Soft Skills

CoachingStrategic ThinkingCollaborationData-Driven Decision MakingEffective Communication

Tools & Technologies

EQMSAI Tools

Industry Keywords

Medical Device QualityIn Vitro Diagnostics (IVD)Quality ControlProduct Lifecycle ManagementSupplier Quality Management

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

Lead and develop Visby’s quality organization
Own a quality management system that is compliant, lean, practical, and scaled to an early-stage company
Lead and grow a team of quality engineers, software quality engineers, and document control specialists
Establish team goals, provide coaching, and develop growth paths
Evolve team structure and staffing plans to meet company objectives
Build quality capability across the company
Participate in day-to-day QMS activities and develop in-depth knowledge of product-quality drivers
Maintain a QMS compliant with FDA QMSR, ISO 13485, and applicable consensus standards
Streamline and improve QMS effectiveness while maintaining compliance
Apply risk-based approaches to determine appropriate process rigor
Evaluate and implement eQMS and other digital tools, including AI
Ensure risk management activities are implemented throughout the product lifecycle
Collaborate with supply chain and subject matter experts on supplier and contractor-manufacturer quality controls
Oversee software quality assurance and software verification activities
Collaborate with stakeholders to implement cybersecurity requirements
Serve as Visby’s quality system management representative and point of contact with external quality system auditors, including FDA
Ensure quality audits are planned and conducted and that effective corrective actions are taken
Provide strategic framework and governance to embed quality throughout the product lifecycle
Align quality objectives with business goals and foster data-driven continuous improvement
Ensure shipped products meet specifications and customer expectations

Requirements

What you’ll need

Bachelor’s degree in engineering, life science or a related field
Advanced degree preferred
10+ years in medical device or IVD quality
5+ years managing and developing quality teams
Experience improving the efficiency and effectiveness of a QMS
Direct experience hosting FDA inspections and/or registrar audits with successful outcomes
In-depth knowledge of relevant regulations and standards, including FDA QMSR and ISO 13485
Proven ability to effectively work with and lead cross-functional teams
Experience with software quality assurance, including cybersecurity preferred
Experience with molecular infectious disease testing preferred
Full COVID vaccination required, with reasonable accommodations for medical or religious reasons considered

Benefits

Comp & perks

Health insurance through United Healthcare or Kaiser
Company-funded HSA option
Flexible paid time off
10 company holidays
Other contemporary benefits and perks
Reasonable accommodations for medical or religious reasons related to COVID vaccination