About the Job
Our mission at ClearPoint Neuro is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders. We are seeking a Quality Engineer to support our quality management system and regulatory requirements at our Carlsbad, CA facility. The ideal candidate is highly organized and detail-oriented and has experience in the medical device field.
Our team members are passionate about growth, innovation and collaboration. We are constantly striving to improve and better ourselves so that we can better help patients and their families. If you have a growth mindset and thrive in a dynamic setting, you could be a great fit for our team!
Company Description
ClearPoint Neuro is a device, cell, and gene therapy-enabling company. We specialize in providing precise navigation to the brain and spine, offering both clinical products and pre-clinical development services for controlled drug and device delivery. With engagements in healthcare and research centers across North America, Europe, Asia, and South America, we are dedicated to improving and restoring the quality of life for patients and their families.
Role Description
We are seeking a Quality Engineer for our Carlsbad, CA office who will be responsible for tasks related to quality engineering, documentation management, training management, design control and product quality.
Skills and Qualifications
- Quality Engineering and Quality Assurance skills
- Quality Control and Product Quality experience
- Solid understanding of design controls and regulatory requirements (e.g., FDA, ISO 13485)
- Knowledge of Quality Management practices
- Strong analytical and problem-solving skills
- Strong attention to detail and exceptional organizational skills
- Excellent written and verbal communication skills
- Ability to work independently, prioritize tasks, and meet deadlines
- Experience with regulatory standards and compliance
- Strong team player, using both internal and external resources to execute activities
- Demonstrates ownership of results within (and beyond) area of responsibility
- Enables and demonstrates the courage to speak up on issues and risks
Education
- Bachelor’s Degree in Engineering or related field