Quality Engineer II - Bothell, WA Relevant Educational Qualifications Job1 month ago - Other categories - Washington Heights - 121 views
The Quality Engineer II is responsible for assisting 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 II will be responsible for driving activity around process validation, as well as participating in establishing and monitoring systems related to Inspection, Testing, Training, Supplier Qualification, New Product Introduction, Manufacturing, Complaints, and Corrective/Preventative Action.
Essential Job Functions:
- The Quality Engineer will be innovative, knowledgeable and intensely committed to ensure that products we supply conform to FDA and ISO Quality System Regulations.
- Understands and is capable of implementing standard approaches to problem prevention and problem solution. Devises new approaches to problems encountered.
- Support new product development in ensuring compliance with Quality System.
- Support Risk Management activities including Failure Mode and Effects Analysis.
- Support Investigation and RMA process for discrepant materials.
- Support supplier qualification and monitoring.
- Review complex complaints or complaint trends and assist in the investigations.
Knowledge and Experience:
- BS or MS degree in Mechanical/Electrical/Industrial Engineering.
- At least 2 years of experience working within the Quality organization of a Medical Device Manufacturer.
- Applications of Lean principles such as Value Stream Mapping, Standard Work, 5S, Kaizen desired.
- Experience with domestic and overseas manufacturing and working directly with Contract Manufacturers and strategic vendors.
- Experience with product lifecycle management (P/N creation, BoM creation, ECO generation and management, AVL management, etc.).
- Quality engineering background and experience with AQLs, product inspections, vendor qualifications and audits.
Skills and Abilities:
- Ability to travel 5% domestically and internationally as needed, sometimes on short notice.
- Proficient in MS Office programs (Word, Excel, PowerPoint), Visio, MS Project; experience with document templates and scientific reference software is desirable.
- Must be detail-oriented with strong written and oral communication skills.
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