Quality Manager
$100k/y-$130k/y
CorDx21 hours ago
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OnsiteFull-timeSenior
Summary
CorDx is seeking a Quality Manager to join their team in San Diego, CA. The role involves ensuring that products and services meet necessary requirements before reaching consumers.
About the Role
As a Quality Manager, you will be responsible for developing effective quality control processes, reviewing product specifications, ensuring compliance with health and safety guidelines, supervising staff, and overseeing product development procedures. You will also conduct internal audits, manage the quality management system, and establish relationships with key opinion leaders and certification bodies to ensure compliance with industry standards.
About You
Required:
- Minimum Bachelor's degree in Science or related field.
- Minimum 10 years of experience in Medical devices, Quality Management, Regulatory compliance, and ISO standards.
- Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards.
- Strong understanding of quality management principles and practices in the medical device industry.
- Excellent communication and interpersonal skills.
- Ability to work collaboratively in a team environment.
- Demonstrated problem-solving and analytical skills.
- Attention to detail and strong organizational skills.
Preferred:
- ISO 13485:2016 lead auditor certification.
Benefits
- Medical Insurance Plan
- Retirement Plan
- Paid Time Off
- Training & Development
CorDx
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
San Diego, CA