Design Quality Engineer
Katalyst CRO · Carlsbad, CA · 2 mo ago
On-siteQuality AssuranceContract
Job Summary
Roles & Responsibilities
- Support quality engineering and design assurance activities within the Medical Device industry.
- Apply risk management principles, design controls, and product verification & validation processes.
- Ensure compliance with global quality system regulations and standards, including ISO 13485 and ISO 14971.
- Utilize advanced quality tools and statistical methodologies where applicable.
Education & Experience
- Bachelor of Science degree in Engineering or a related technical field.
- Minimum 3 years of experience in quality engineering or design assurance within the Medical Device industry.
- PREFERRED: Degree in Biomedical Engineering or Mechanical Engineering.
- PREFERRED: Experience supporting structural heart, cardiovascular, or implantable medical devices.
- PREFERRED: Certification in Quality Engineering (CQE) or related credential.