Principal Engineer, Quality Assurance

4 days ago


Irvine, California, United States Edwards Lifesciences Full time
Job Summary

Edwards Lifesciences is seeking a highly skilled Principal Quality Assurance Engineer to join our team. As a Principal Quality Assurance Engineer, you will be responsible for ensuring the quality of our medical devices and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Develop and implement quality assurance processes and procedures to ensure compliance with regulatory requirements.
  • Conduct audits and assessments to identify areas for improvement and implement corrective actions.
  • Collaborate with cross-functional teams to ensure quality is integrated into all aspects of product development and manufacturing.
  • Develop and maintain technical documentation, including quality procedures, work instructions, and training materials.
  • Provide training and guidance to colleagues on quality assurance processes and procedures.
Requirements
  • Bachelor's degree in a relevant field, such as engineering or life sciences.
  • Minimum 6 years of experience in quality assurance, with a focus on medical devices.
  • Proven experience in developing and implementing quality assurance processes and procedures.
  • Strong knowledge of regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
  • Excellent communication and interpersonal skills.
Preferred Qualifications
  • Master's degree in a relevant field.
  • Experience with quality management systems, such as ISO 13485.
  • Knowledge of statistical process control and quality metrics.
  • Experience with training and development programs.
What We Offer

Edwards Lifesciences offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

We are an equal opportunity employer and welcome applications from diverse candidates.



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