Demo

QA Senior Engineer I

EPM Scientific
Santa Barbara, CA Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 4/25/2025

The Senior Quality Engineer to join the team, will work with cutting-edge orthopedic and software surgical devices. This role involves ensuring product quality and compliance from design through manufacturing.

Key Responsibilities :

  • Represent Quality Assurance in product design and development projects.
  • Ensure compliance in manufacturing and repair activities.
  • Lead quality process improvements and analyze trends.
  • Approve and document product and process changes.
  • Manage nonconformance resolutions and corrective actions.
  • Support and mentor quality team members.

Qualifications :

  • Bachelor's degree in Engineering required.
  • 5 years in Quality Control / Assurance, ideally in medical devices.
  • Experience with capital equipment and software validation REQUIRED.
  • Proficiency in risk assessments, design control, SPC, and process improvement.
  • Knowledge of FDA, ISO13485, ISO14971, and medical device regulations.
  • If you are interested and would like to learn more, send your resume to adam.tizabi@epmscientific.com

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