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Design Quality Engineer
Job in
Carlsbad, San Diego County, California, 92002, USA
Listed on 2026-07-01
Listing for:
Creative Solutions Services, LLC
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist, Mechanical Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
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.
- 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.
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