Quality Assurance Engineer I

Earlens • Menlo Park, CA

32d

About The Position

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.

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
• 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

Nice To Haves

• Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus

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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Number of Employees: 101-250 employees