Fremont, CA
Job Title: Quality Engineer
Location: Fremont, CA
Pay: $90k-$100k
About the job:
The Quality Engineer will ensure compliance with regulatory standards and support continuous improvement in manufacturing processes and products. This role collaborates with cross-functional teams to maintain quality systems, investigate non-conformances, and drive initiatives that enhance product quality and efficiency.
We’re looking for someone who:
• Has a bachelor’s degree in Engineering, Quality Assurance, or a related field (advanced degree preferred)
• Brings 5+ years of quality engineering experience in the medical device industry
• Understands ISO 9001, ISO 13485, and CFR 820 standards and requirements
• Excels at root cause analysis, CAPA management, and NCR resolution
• Is detail-oriented, analytical, and committed to compliance and quality excellence
• Communicates effectively and works collaboratively with cross-functional teams
• (Preferred) Has experience with cleanroom operations and contamination control practices
• (Preferred) Has experience in supplier quality management, including audits and SCARs
• (Preferred) Holds CQE or CQA certification
What you’ll do:
• Investigate and resolve non-conformances, deviations, and customer complaints using CAPA
methodologies
• Generate and manage CAPAs, NCRs, and corrective actions to ensure timely resolution
• Update and revise SOPs, quality procedures, and work instructions for compliance and efficiency
• Perform inspections of finished goods, raw materials, and components to verify compliance with
specifications
• Oversee equipment calibration and ensure accuracy of test and measurement systems
• Provide quality-related guidance and support to manufacturing teams
• Conduct supplier audits and assessments to evaluate performance and compliance
• Participate in cleanroom activities and ensure compliance with ISO 14644 standards
• Analyze data, identify trends, and implement best practices to drive continuous improvement
Why you’ll love working here:
• Weekly pay
• Paid sick leave
• Health, vision, dental, pet insurance, and more