What are the responsibilities and job description for the Quality Assurance Engineer I position at EarLens Corporation?
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
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Support production teams on all manufacturing-related quality needs
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Administer supplier management processes
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Coordinate equipment calibration and preventive maintenance tracking
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Manage CAPA documentation, follow-up, and closure
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Maintain training compliance records
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Enter and track customer complaints in accordance with regulatory requirements
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Support quality metrics reporting and system activity tracking
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Identify and implement process improvement opportunities
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Assist with documentation simplification, workflow charts, data analytics, and general administrative support
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Perform other quality engineering tasks as assigned
Qualifications
Minimum Requirements
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Bachelors degree in engineering (preferably Mechanical or Biomedical) from an accredited institution
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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
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Ability to interpret technical drawings and specifications
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Strong analytical thinking and problem-solving skills
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Excellent verbal and written communication
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Comfortable working in a fast-paced, dynamic environment
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Proficient in Microsoft Word and Excel
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Strong collaborator with a do the right thing mindsetunafraid to surface and address quality concerns
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Meticulous attention to detail, particularly with documentation
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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.