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Quality Engineer

Full Time
Issaquah, WA 98029
$45 - $47 an hour
Posted 3 days ago
Job description

Job Title: Quality Engineer

Location: Issaquah, WA 98029

Duration: 10 Months

Job Description:

· The candidate should have experience with FDA QSR and ISO13485 requirements and experience in medical device manufacturing quality systems.

· Review and approve new manufacturing processes or changes to manufacturing processes to ensure compliance to established procedures.

· Understands regulatory process validation in a medical device manufacturing environment and ensures processes are validated appropriately through review of protocols and resulting validation reports.

· Ensures that nonconforming material is dispositioned appropriately by utilizing established non-conforming handling systems.

· Understands component and product acceptance requirements and ensures these requirements are implemented appropriately in manufacturing.

· Reviews and approves engineering change orders related to supply chain management and manufacturing.

· Proactively reviews manufacturing data and participates in special projects related to the continuous improvement activities.

· Monitor calibrated equipment to ensure timely calibration and thorough investigation of calibrated equipment received out of tolerance.

· Follow lead QE direction and guidance in performing day to day activities where help is needed.


· BA/BS with5+ years of experience working in a GMP regulated industry and good working knowledge of FDA and international medical device regulations with 3+ years in manufacturing of medical devices.

· ASQ CQE or other certifications a plus.

Job Type: Contract

Salary: $45.00 - $47.00 per hour


  • 8 hour shift
  • Day shift
  • Monday to Friday

Ability to commute/relocate:

  • Issaquah, WA 98029: Reliably commute or planning to relocate before starting work (Required)


  • Bachelor's (Required)


  • ISO 13485: 5 years (Required)
  • FDA regulations: 5 years (Required)
  • GMP/Manufacturing: 5 years (Required)
  • Medical Devices: 5 years (Required)

Work Location: One location

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