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Quality Engineer

2 months ago

Carlsbad, United States ClearPoint Neuro, Inc. Full time

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

This is a full-time on-site role for a Quality Engineer at ClearPoint Neuro in Carlsbad, CA,. The Quality Engineer will be responsible for tasks related to quality engineering, design control, product quality, documentation management and training management.


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
  • Bachelor's degree in Engineering or related field