Quality Engineer 3
Posted on :
26-10-2022
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Job Description
Description:
The candidate should have experience with FDA QSR and ISO13485 requirements and experience in medical device manufacturing quality systems.
S/He will:
S/He will:
- 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.
This position is working onsite at the Issaquah, WA location.
Minimum Requirements: BA/BS required.
- Five (5) plus years of experience working in a GMP regulated industry and good working knowledge of FDA and international medical device regulations with three (3) plus years in manufacturing of medical devices. Effective writing and communication skills. ASQ CQE or other certifications a plus.
Employment Type
Full Time
Key Skills
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