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Novir

Posted 1 month ago

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Quality Assurance Manager

MilwaukeeOn-site

AI Summary

The Quality Assurance Manager will lead the development and maintenance of a Quality Management System (QMS), ensuring regulatory compliance (ISO 13485, IVDR, FDA) and overseeing product quality assurance and risk assessment initiatives.

About this role

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.

What You'll Do:

  • Total Quality Management System (TQMS): Develop, implement, and maintain a robust QMS to ensure compliance with regulatory requirements and internal standards. Oversee the continuous improvement of QMS processes, including documentation, supplier qualification, audits, and corrective/preventive actions.
  • Team Leadership and Development: Lead and mentor the team, fostering a culture of continuous improvement and accountability. Provide training and development opportunities to enhance the skills and knowledge of the quality assurance team.
  • Regulatory Compliance: Stay on top of industry regulations and standards related to manufacturing of products, including IVDR
  • Risk Assessment and Management: Implement effective risk mitigation strategies to minimize potential quality and safety risks throughout the supply chain. Collaborate with cross-functional teams to integrate mitigation strategies into overall operational practices.
  • Customer Complaint Management and Investigation: Maintain a robust system for receiving, investigating & resolving customer complaints related to product quality and safety. Analyze complaint trends using statistical methods to gain insights to allow for targeted improvements. Ensure corrective actions are implemented and champion continuous improvement measures based on customer feedback.
  • Implement Process improvements: Executeongoing projects of process improvements to address key quality and customer issues, and to engrain the QMS into the company activities.
  • Product Quality Assurance: Oversee Quality Control process for products serving EU and US, collaborate with cross-functional teams to establish and enforce product quality specifications, ensuring consistency and adherence to brand standards. Conduct regular product quality inspections and lead investigations into any deviations from established standards.
  • Supplier Quality: Work closely with product suppliers to establish and maintain high-quality materials. Develop and implement supplier quality assurance programs to monitor and improve supplier performance.
  • Data Analysis and Reporting: Utilize data-driven insights to identify trends, areas for improvement, and opportunities for innovation. Prepare and present regular reports to executive leadership on quality metrics, compliance status, and improvement initiatives.

    • Key Experience We're Looking For:

  • 6+ years of progressive experience in quality assurance with 3+ years of experience in a leadership (people management) role
  • Bachelor’s degree in a related field preferred
  • Extensive knowledge of regulatory requirements, quality standards, and industry best practices related to IVD products
  • Demonstrated experience in managing budgets, setting strategic goals, and delivering results in a fast-paced, dynamic environment
  • Exceptional leadership and communication skills, with the ability to influence and inspire cross-functional teams to drive successful product safety and quality improvement initiatives
  • Black Belt certified preferred
  • Experience with ISO13485 certification

    • Perks of Working @ Novir:

  • Competitive total compensation offerings
  • Generous paid time off policy
  • Medical, dental and vision insurance, some of which is covered by the company
  • Company provided Disability and Life Insurance
  • Flexible schedule and work from home policy
  • A friendly office atmosphere in our office space in the heart of Milwaukee’s Third Ward
  • Opportunity to build something incredible while being surrounded by intelligent, hardworking and motivated coworkers

    • Skills

    Corrective And Preventive Actions (CAPA)FDAISO13485IVDRQMSRisk AssessmentStatistical Process Control (SPC)Supplier Qualification

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