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Quality Assurance Manager

NovirMilwaukee🇺🇸United StatesPosted Dec 13, 2022

Quick overview

SeniorityMid Senior
Employment typeFTE
Work modeOn Site
LocationMilwaukee, United States
Posted3 years ago
ComplianceContinuous ImprovementFDA RegulationsRisk Assessment

Job description

Who We Are
Novir is a pioneering preventive health technology company dedicated to providing accessible and reliable diagnostic testing solutions and preventive healthcare services. Key offerings include a product portfolio with self-test and professional use products (IVDs) currently offered in EU, virtual drug testing solutions including products for employee use only, and onsite health services with vaccinations and screening serving the senior living space. Novir’s mission is to improve health outcomes by early detection in offering innovative testing products and services in key markets worldwide.
What We Do
Our product offering is currently focused on sales into EU with IVDs for professional use and self-testing. All products abide IVDR or FDA regulations and local rules in each key country, currently including Nordics and Iberia. Products are in general lateral flow assays which deliver reliable rapid results to drive early detection and organized into two main families: drug testing products serving mainly clinical customers (EU) and workplace (USA), and general health products through retail channels (EU). Novir has an established QC function in Milwaukee at Novir Research Park Lab, is ISO13485 certified and has a QMS to support it. Novir currently works with contract manufacturers for its Novir branded products and part of the roadmap includes bringing in manufacturing capabilities domestically and to add research function at the Laboratory.
About The Role:
The Quality Assurance Manager will lead the continuous development and maintenance of a Quality Management System (QMS) to ensure compliance with regulatory requirements, incl. ISO 13485 status, while also overseeing product quality assurance and risk assessment initiatives. This role collaborates with cross-functional teams to establish product and process quality specifications, to develop or drive improvements and to ensure compliance with regulatory bodies and local regulations. The QA manager will foster culture of continuous improvement within the organization and an integration of the quality management system into every process and product aspect of the companies’ everyday activities to deliver products and services safely and to great customer satisfaction.
The ideal candidate for this role is an process oriented with deeper analytical skills, strategic and collaborative leader, possessing a deep understanding of quality management systems and key regulations such as IVDR and FDA, a meticulous attention to detail, a proactive approach to problem-solving, and a passion for delivering products that exceed customers’ expectations.

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