About the Job
The Director of Quality will lead and develop Visby's quality organization and own a quality management system that is fully compliant and also lean, practical, and scaled to an early-stage company. You’ll lead and grow an established team and key stakeholders to ensure the QMS is both effective and efficient. You’ll serve as Visby's quality management representative with FDA and other auditors.
Responsibilities:
Leadership
Lead, develop, and retain a high-performing team of quality engineers, software quality engineers, and document control specialists, with clear goals, regular coaching, and growth paths.
Evolve the team's structure and staffing plan to meet company objectives.
Build quality capability across the company, so quality is shared by every function.
Act as a servant leader by actively participating in the day-to-day QMS activities and develop an in-depth knowledge of the key drivers of product quality across the organization.
Effective and Efficient QMS
Maintain a QMS compliant with FDA QMSR, ISO 13485, and applicable consensus standards, sized to Visby's stage, risk profile, and growth.
Continually streamline and improve the effectiveness of the QMS while maintaining compliance and focusing the product quality.
Use risk-based approaches to decide where rigor is needed and where a lighter process is enough.
Evaluate and implement eQMS and other digital tools (including AI) that improve efficiency
.Ensure that risk management activities are effectively implemented throughout the product lifecycle and used to drive product quality improvements
Product, Supplier and Software Quality
Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers through supplier controls.
Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements.
Compliance and Audits
Serve as the company’s quality system management representative and serve as the company point of contact with external quality system auditors (e.g., FDA)
Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed.
How Your Position will impact product quality and achievement of the quality objectives
You will provide the strategic framework and governance necessary to embed quality in every stage of the product lifecycle. By aligning quality objectives with business goals you will foster a data-driven culture of continuous improvement and ensure that every shipped product meets the specifications and customer expectations.
On Your First Day We’d Like You to Have
A bachelor’s degree in engineering, life science or a related field, an advanced degree preferred.
10+ in medical device or IVD quality, including 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 (e.g., FDA QMSR, ISO 13485)
Proven ability to effectively work with and lead cross-functional team.
It’s Great If You Have
Experience with software quality assurance, including cybersecurity.
Experience with molecular infectious disease testing.
More About the Team
You will lead a team of experienced quality professionals, including quality engineers, software quality engineers, and document control specialists. The team works c