Quality Assurance Engineer I
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Job Location:
Menlo Park, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
About the Role
Were 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. Youll 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
Bachelors 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 mindsetunafraid 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. Youll gain exposure across operations quality systems and continuous improvement while helping deliver life-changing solutions to our customers.
Key Skills
- Test Cases
- Performance Testing
- Quality Assurance
- SOC
- Agile
- Debugging
- Jira
- Perl
- Software Testing
- Test Automation
- Scripting
- Selenium
About Company
Earlens is the world's first and only hearing aid solution to directly vibrate the eardrum, delivering a more complete sound than any other hearing aid.
