Quality Engineer

$90k - $100k

Slingshot Connections

Fremont, CA

Fremont, CA

Order: 1706382

Order Type : Temp

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

Apply

Vacancy posted 4 days ago

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