Biomedical Engineering, Cardiovascular, Certified Quality Engineer (CQE), ISO (International Organization for Standardization), Implants, Maintain Compliance, Mechanical Engineering, Medical Equipment, Product Design, Product Testing, Quality Engineering, Regulations, Risk Management, Technical/Engineering Design, Validation Testing
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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Katalyst Healthcares & Life Sciences