Design Quality Engineer

Katalyst HealthCares and Life Sciences

• $90K — $120K *
Carlsbad, CA 92009In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor of Science degree in Engineering or a related technical field.
  • Minimum 3 years of experience in quality engineering or design assurance within Medical Device industry.
  • Preferred degree in Biomedical Engineering or Mechanical Engineering.
  • Experience with structural heart, cardiovascular, or implantable medical devices preferred.
  • Certification in Quality Engineering (CQE) or related credential preferred.

Responsibilities

  • Support quality engineering and design assurance activities.
  • Apply risk management principles, design controls, and product verification & validation processes.
  • Ensure compliance with global quality systems and standards.
  • Utilize advanced quality tools and statistical methodologies.

Benefits

  • Comprehensive health benefits.
  • Retirement plan options.
  • Professional development opportunities.
Full Job Description
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.
  • pply 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.
* Ladders Estimates

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