Medical Device Quality Engineer
3 weeks ago
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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