Design Quality Engineer

Katalyst HealthCares & Life Sciences

Job-ID32491148Reference26-01072 Job Summary: 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. 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. Experience supporting structural heart, cardiovascular, or implantable medical devices preferred. Certification in Quality Engineering (CQE) or related credential preferred.

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