Job Title: Quality Engineer
Location: Issaquah, WA 98029
Duration: 10 Months
· 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