KH
Design Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
3 months ago
- Risk Management
3 months ago
Not enough detail in this posting to match
- Quality Engineer with experience in the Medical Device industry, specializing in quality engineering, design assurance, risk management, design controls, and product verification & validation. Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
- 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.
- 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.
- Experience supporting structural heart, cardiovascular, or implantable medical devices preferred.
- Certification in Quality Engineering (CQE) or related credential preferred.
Design Quality Engineer · Katalyst Healthcares & Life Sciences