Unifize

We founded Unifize in 2019 to provide a collaborative, cloud-based platform for ISO and FDA-compliant companies. Our platform brings together quality, operations, and product development teams, giving them a unified system for managing risk, improving efficiency, and accelerating innovation. It combines conversations, documents, data, and workflows throughout the entire process, making everything more transparent and easier to track.

We offer several core products:

• Document Management System: Simplifies document control, training, and regulatory compliance.
• Quality Management System (QMS): Ensures regulatory compliance, reduces quality risks, and helps companies prepare for audits. It handles non-conformances/defects, root cause analyses, corrective actions, internal audits, and inspections.
• Product Lifecycle Management (PLM): Speeds up product development and improves traceability.
• Manufacturing Execution System (MES): Offers real-time visibility and helps optimize production processes.

Our platform is highly configurable with a no-code process builder, role-based dashboards, and access controls. For collaboration, we include chat, vendor/customer portals, CFR Part 11 compliant eSignatures, and real-time audit trails. Automation features cover revision management, workflow routing, notifications, and approval processes. We offer API access, native connectors for tools like Slack and SharePoint, and custom integration services for systems such as ERPs and CRMs. Our analytics and reporting tools provide configurable dashboards and real-time metrics. The platform has enterprise-grade security, including role-based access control, SOC-2 compliance, and options for ITAR, NIST, and HIPAA compliance with Azure.gov hosting for government agencies.

We work with quality and operations teams in life science and manufacturing companies with 5 to 5000 employees. Our clients come from industries like Life Sciences, Medical Devices, Nutritional Supplements, Biotechnology, Cosmetics, Pharmaceuticals, Food and Beverage, Automotive, Aerospace & Defense, Electronics, Machinery, and Logistics.

Our vision is to help organizations worldwide that comply with complex external standards and regulations to both innovate and stay compliant. Our mission is to help companies meet ISO or FDA regulations by providing an integrated platform that improves collaboration, ensures compliance, and drives efficiency.

Our core values are innovation, first principles thinking, people first, collaboration, efficiency, and radical transparency.

We are a team of 11 to 50 employees, founded in 2019. Our technologists have over 15 years of experience in quality operations within life science and manufacturing companies. We foster a work environment that emphasizes continuous improvement, operational excellence, and human-centered innovation.

We aim to solve real-world problems for product development, quality, and operations teams by unifying fragmented systems into a single source of truth. Customer success is central to us; we offer white-glove onboarding and dedicated customer success managers. Some roles have a hybrid work model, collaborating across US time zones, which supports a flexible work environment.

We offer our employees a competitive salary and impactful roles within a fast-growing SaaS company. You’ll gain exposure to global customers and regulated industries, with opportunities to grow into leadership positions like Implementation Lead or Customer Success Lead. We also provide a flexible work environment.