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Quality Assurance Engineer I

Quality Assurance Engineer I

Earlens CorporationMenlo Park, CA, United States
1 day ago
Job type
  • Full-time
Job description

About the Role

We're seeking a Quality Assurance Engineer I to support critical Quality Management System functions within our manufacturing operations. This role is ideal for an early career engineer looking to make an immediate impact in a fast-paced medical device environment. You'll help manage supplier quality, drive corrective actions, support compliance, and contribute to continuous improvement initiatives that directly influence patient outcomes.

Key Responsibilities

  • Support production teams on all manufacturing-related quality needs
  • Administer supplier management processes
  • Coordinate equipment calibration and preventive maintenance tracking
  • Manage CAPA documentation, follow-up, and closure
  • Maintain training compliance records
  • Enter and track customer complaints in accordance with regulatory requirements
  • Support quality metrics reporting and system activity tracking
  • Identify and implement process improvement opportunities
  • Assist with documentation simplification, workflow charts, data analytics, and general administrative support
  • Perform other quality engineering tasks as assigned

Qualifications

Minimum Requirements

  • Bachelor's degree in engineering (preferably Mechanical or Biomedical) from an accredited institution
  • Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred
  • Key Competencies

  • Ability to interpret technical drawings and specifications
  • Strong analytical thinking and problem-solving skills
  • Excellent verbal and written communication
  • Comfortable working in a fast-paced, dynamic environment
  • Proficient in Microsoft Word and Excel
  • Strong collaborator with a "do the right thing" mindset-unafraid to surface and address quality concerns
  • Meticulous attention to detail, particularly with documentation
  • Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus
  • Why Join Us?

    This is a unique opportunity to grow your engineering career within a highly innovative medical device organization. You'll gain exposure across operations, quality systems, and continuous improvement while helping deliver life-changing solutions to our customers.

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    Quality Assurance Engineer • Menlo Park, CA, United States

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