Quality Engineer - Electromechanical Medical Devices (Entry Level)

BioSpace

Pleasanton (CA)

On-site

USD 108,393 - 122,000

Full time

14 days+

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Benefits offered by this job

Paid time off
Medical, dental, and vision insurance
401(k) plan

Job summary

A leading biopharmaceutical company in California is seeking a Quality Engineer focused on Electromechanical Medical Devices. This role involves supplier quality management, conducting statistical analysis, and ensuring compliance with FDA regulations. The ideal candidate will have a Bachelor's degree in engineering and relevant quality engineering experience in medical device manufacturing. Competitive salary and benefits included.

Qualifications

  • Must have 1 year of quality engineering experience in FDA regulated medical device manufacturing.
  • Experience in conducting statistical analyses for quality assessments.
  • Experience in supporting quality system management and process controls.

Responsibilities

  • Manage supplier quality management cycle effectively.
  • Oversee supplier audits and quality improvement initiatives.
  • Conduct verification and validation for processes and products.

Skills

Statistical analysis
Supplier quality management
Cross-functional team collaboration

Education

Bachelor's degree in engineering

Tools

Gage Repeatability & Reproducibility
DoE
SPC

Job description

A leading biopharmaceutical company in California is seeking a Quality Engineer focused on Electromechanical Medical Devices. This role involves supplier quality management, conducting statistical analysis, and ensuring compliance with FDA regulations. The ideal candidate will have a Bachelor's degree in engineering and relevant quality engineering experience in medical device manufacturing. Competitive salary and benefits included.
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