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Energy Jobline ZR

Quality Engineer - Medical Device Industry in Fremont

Energy Jobline ZR, Fremont, California, us, 94537

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Job Description + 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 )

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

() Has experience with cleanroom operations and contamination control practices

() Has experience in supplier quality management, including audits and SCARs

() 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

Company Description SlingShot Connections provides contract staffing, direct hire placement, executive search recruitment, payroll services, and customized staffing solutions for numerous verticals, including accounting & finance, hospitality, human resources, and many more.

If you are interested in applying for this job please press the Apply Button and follow the application process. Energy Jobline wishes you the very best of luck in your next career move.

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