Job Information
Fujifilm Sonosite Quality Engineer III in Bothell, Washington
Summary:
The Quality Engineer III is responsible for taking the lead in establishing, implementing, and maintaining systems and/or services to measure and improve product quality, cost, and customer service while ensuring full compliance to FDA and applicable ISO requirements. The Quality Engineer III will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Inspection, Training, Supplier Qualification, New Product Introduction, Complaints, and Corrective/Preventative Action.
Essential Job Functions:
- Innovative thinker, knowledgeable and intensely committed to ensure that products we supply conform to the FDA Quality System Regulation and ISO 13485.
- Takes lead of implementing standard approaches to problem solving and
- prevention. Devises creative approaches to solving problems encountered.
- Take lead on new product development in ensuring compliance with Quality System requirements.
- [Partner with R&D and Operations in the development of verification and ]{arial",="" sans-serif"=""}validation protocols for product designs and manufacturing processes.
- Identify, plan, and participate in the implementation of process improvements.
- [Oversee Risk Management activities including Failure Mode and Effects]{arial",="" sans-serif"=""}Analysis.
- Lead the MRB process for discrepant material investigations and decisions.
- Support supplier qualification and monitoring.
- Review complex complaints and complaint trends and participate in failure investigations.
- Support development and continuous improvement of quality system procedures.
- Report to management on quality issues and trends.
- [Available to be on calls in the morning or evening with global contract ]{arial",="" sans-serif"=""}manufacturers and suppliers in other time zones.
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