Director of Quality

Visby Medical•San Jose, CA

1d•$200,000 - $230,000

About The Position

Visby Medical is an early-stage in vitro diagnostics company developing a diagnostic device platform intended to make infectious disease testing quick, accurate, and accessible. The Director of Quality will lead and develop Visby's quality organization and own a quality management system (QMS) that is compliant, lean, practical, and appropriately scaled to the company. This role leads an established team and works with key stakeholders to ensure the QMS is effective and efficient, and serves as Visby's quality management representative and point of contact with the FDA and other auditors. The Director will provide the strategic framework and governance to embed quality throughout the product lifecycle, align quality objectives with business goals, foster data-driven continuous improvement, and ensure shipped products meet specifications and customer expectations. The role leads experienced quality professionals, including quality engineers, software quality engineers, and document control specialists.

Requirements

Bachelor's degree in engineering, life science, or a related field.
10+ years of experience in medical device or IVD quality.
5+ years managing and developing quality teams.
Experience improving QMS efficiency and effectiveness.
Direct experience hosting FDA inspections and/or registrar audits with successful outcomes.
In-depth knowledge of relevant regulations and standards, such as FDA QMSR and ISO 13485.
Proven ability to work effectively with and lead cross-functional teams.

Nice To Haves

Advanced degree.
Experience with software quality assurance, including cybersecurity.
Experience with molecular infectious disease testing.

Responsibilities

Lead, develop, and retain a high-performing team of quality engineers, software quality engineers, and document control specialists, setting clear goals, providing regular coaching, and supporting career growth.
Evolve the team's structure and staffing plan to meet company objectives.
Build quality capability across the company and promote shared responsibility for quality across functions.
Participate in day-to-day QMS activities and develop an in-depth understanding of the key drivers of product quality across the organization.
Maintain a QMS compliant with FDA QMSR, ISO 13485, and applicable consensus standards, scaled to the company's stage, risk profile, and growth.
Continuously streamline and improve QMS effectiveness while maintaining compliance and focusing on product quality.
Apply risk-based approaches to determine where rigorous controls are needed and where lighter processes are appropriate.
Evaluate and implement eQMS and other digital tools, including AI, to improve efficiency.
Ensure risk management activities are effectively implemented throughout the product lifecycle and used to drive product quality improvements.
Collaborate with supply chain and subject matter experts to ensure supplier and contractor-manufacturer quality and reliability through supplier controls.
Oversee software quality assurance, including software verification, and collaborate with stakeholders on cybersecurity requirements.
Serve as the company's quality system management representative and point of contact for external quality system auditors, including the FDA.
Ensure quality audits are planned and conducted and that effective corrective actions are taken when needed.
Align quality objectives with business goals, support data-driven continuous improvement, and help ensure shipped products meet specifications and customer expectations.