Medical Device Quality Engineer

3 weeks ago


Wilmington, Massachusetts, United States restor3d Full time
Quality Engineer Position Summary

Join restor3d's team of innovators and contribute to the development and implementation of our quality system. As a Quality Engineer, you will play a key role in ensuring the quality of our implantable medical devices and maintaining compliance with regulatory requirements. If you have a passion for quality management and want to make a real difference in the lives of our patients and surgeons, we encourage you to apply.

Estimated salary: $90,000 - $120,000 per year, depending on experience.

About the Role

This is an exciting opportunity to join a dynamic team and contribute to the success of restor3d. As a Quality Engineer, you will be responsible for:
  • Implementing quality system processes to support production of safe and effective implantable medical devices.
  • Identifying and implementing solutions for continuous improvement of the quality system, Quality Control inspection lab, manufacturing processes, and product designs.
  • Developing and maintaining strong internal working relationships across the company.
  • Understanding the objectives, responsibilities, and mission of the Quality department and working towards those goals.
  • Prioritizing and planning work activities; adapting for changing conditions.

Requirements and Qualifications

To be successful in this role, you will need:
  • Bachelor of Science in Engineering, Mechanical Engineering, Science, Biomedical, or Materials Science.
  • 0 – 5 years of experience with a comprehensive knowledge of Medical Device regulations including FDA 21 CFR 820 and other applicable international standards with hands-on experience in working within a quality system under regulatory requirements.
  • Proficiency with Microsoft Office (Word, Excel, PowerPoint).
  • Ability to travel as needed (


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