Quality Engineer: Medical Devices at Collate

San Francisco, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

This Quality Engineer position requires a Bachelor’s degree in Engineering, preferably Biomedical or Mechanical, and a minimum of 5 years of experience in quality engineering within the medical device industry. Strong analytical and problem-solving skills are essential, along with a thorough understanding of ISO 13485 and FDA regulations. Experience with risk management methodologies such as FMEA and control plans is also necessary.

Responsibilities

The Quality Engineer will be responsible for developing and implementing quality systems, conducting internal audits, managing corrective and preventive actions, and ensuring compliance with regulatory requirements. They will also contribute to product design, analyze quality data, and support process improvement initiatives to maintain high product quality and patient safety.