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EarLens Corporation

Quality Assurance Engineer I at EarLens Corporation

EarLens Corporation Menlo Park, CA

Job Description

About the RoleWere 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 ResponsibilitiesSupport production teams on all manufacturing-related quality needsAdminister supplier management processesCoordinate equipment calibration and preventive maintenance trackingManage CAPA documentation follow-up and closureMaintain training compliance recordsEnter and track customer complaints in accordance with regulatory requirementsSupport quality metrics reporting and system activity trackingIdentify and implement process improvement opportunitiesAssist with documentation simplification workflow charts data analytics and general administrative supportPerform other quality engineering tasks as assignedQualificationsMinimum RequirementsBachelors degree in engineering (preferably Mechanical or Biomedical) from an accredited institutionExperience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality manufacturing or product development preferredKey CompetenciesAbility to interpret technical drawings and specificationsStrong analytical thinking and problem-solving skillsExcellent verbal and written communicationComfortable working in a fast-paced dynamic environmentProficient in Microsoft Word and ExcelStrong collaborator with a do the right thing mindsetunafraid to surface and address quality concernsMeticulous attention to detail particularly with documentationWorking knowledge of programming languages (Python JavaScript SQL or Visual Basic) a plusWhy Join UsThis 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 Employment Type : Full Time Experience: years Vacancy: 1

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