Director of Quality

Visby Medical•San Jose, CA

About The Position

Visby Medical is an early-stage in vitro diagnostics company developing a diagnostic device platform for infectious disease testing. The Director of Quality will lead and develop the quality organization and own a quality management system (QMS) that is compliant, lean, practical, and appropriately scaled to the company’s stage. The role leads an established team and works with stakeholders to ensure the QMS is effective and efficient, while serving as the company’s quality management representative and point of contact for FDA and other external auditors. The Director will provide strategic governance to embed quality throughout the product lifecycle, align quality objectives with business goals, foster data-driven continuous improvement, and help ensure shipped products meet specifications and customer expectations. The position leads 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 or more years of experience in medical device or IVD quality.
5 or more 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, such as FDA QMSR and ISO 13485.
Proven ability to work effectively with and lead cross-functional teams.
Full COVID vaccination is required; reasonable accommodations for medical or religious reasons are considered.

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 through clear goals, coaching, and growth paths.
Evolve the quality 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 in-depth knowledge of the factors affecting product quality.
Maintain a QMS compliant with FDA QMSR, ISO 13485, and applicable consensus standards, appropriately scaled to the company’s stage, risk profile, and growth.
Streamline and improve QMS effectiveness while maintaining compliance and focusing on product quality.
Use risk-based approaches to determine where rigorous controls or lighter processes are appropriate.
Evaluate and implement eQMS and other digital tools, including AI, to improve efficiency.
Ensure risk management activities are implemented across the product lifecycle and used to drive product quality improvements.
Collaborate with supply chain and subject matter experts to ensure supplier and contract 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 FDA auditors.
Ensure quality audits are planned and conducted and that effective corrective actions are taken when needed.
Provide strategic quality governance across the product lifecycle, align quality objectives with business goals, support continuous improvement, and ensure shipped products meet specifications and customer expectations.