Novir
Quality Assurance Manager
Milwaukee, WI
Sponsorship not specifiedDetected 1317 days ago
Data AnalysisComplianceFDA RegulatoryMedical DevicesResearchLeadershipProblem Solving
About the role
- ISO 13485 status, while also overseeing product quality assurance and risk assessment initiatives.
- Oversee the continuous improvement of QMS processes, including documentation, supplier qualification, audits, and corrective/preventive actions.
Responsibilities
- Total Quality Management System (TQMS): Develop, implement, and maintain a robust QMS to ensure compliance with regulatory requirements and internal standards.
- 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.
- 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.
- 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.
- Implement effective risk mitigation strategies to minimize potential quality and safety risks throughout the supply chain.
Requirements
- Provide training and development opportunities to enhance the skills and knowledge of the quality assurance team.
Benefits
- Who We Are Novir is a pioneering preventive health technology company dedicated to providing accessible and reliable diagnostic testing solutions and preventive healthcare services.
- Novir's mission is to improve health outcomes by early detection in offering innovative testing products and services in key markets worldwide.
- Perks of Working @ Novir:
Company info
- Novir is a pioneering preventive health technology company dedicated to providing accessible and reliable diagnostic testing solutions and preventive healthcare services.
- 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.
- 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.
- Our product offering is currently focused on sales into EU with IVDs for professional use and self-testing.
- 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 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.
- Key Experience We're Looking For:
This listing is sourced directly from Novir's careers page and normalized into a canonical job model.