Quality Manager
CorDxSan Diego, California, United States
Posted October 23, 2024
100000 - 130000 USD year
Full Time
About the Company
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare. #Biotechnology #Pharmaceuticals #Diagnostics #Healthcare #PersonalisedHealthcare #GreatPlaceToWork #Innovation
Job Description
We are seeking an experienced Quality Manager to ensure product and service quality standards are met. This role involves inspecting final products to comply with legal and customer expectations, managing data, conducting audits, and collaborating with regulatory bodies. The ideal candidate will be thorough, detail-oriented, and possess a strong understanding of medical device quality systems.
Requirements
- Understand customer needs and requirements to develop effective quality control processes
- Develop and review specifications for products or processes
- Ensure adherence to health and safety guidelines as well as legal obligations
- Supervise inspectors, technicians and other staff and provide guidance and feedback
- Oversee all product development procedures to identify deviations from quality standards
- Inspect final output and compare properties to requirements
- Approve the right products or reject defectives
- Maintain accurate documentation and perform statistical analysis
- Solicit feedback from customers
- Submit detailed reports
- Implement, manage, and improve the company’s quality management system
- Conduct internal audits, compile audit reports, perform problem analysis, and propose improvement initiatives
- Oversee the quality management system for IVD equipment
- Perform statistical analysis of IVD equipment quality data
- Update company documents
- Establish collaborative relationships with key opinion leaders
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
