Quality Engineer III - Bothell, WA Relevant Educational Qualifications Job1 month ago - Other categories - Bothell - 100 views
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. Also as the Quality Engineer III you will take ownership in creating, updating and executing manual test plans, along with creating, updating and execute automated test scripts.
ESSENTIAL JOB FUNCTIONS:
- The Quality Engineer III will be innovative, knowledgeable and intensely committed to ensure that products we supply conform to FDA and ISO Quality System Regulations.
- Takes lead of implementing standard approaches to problem prevention and problem solution.
- Devises new approaches to problems encountered.
- Take lead on new product development in ensuring compliance with Quality System.
- Responsible for the development, maintenance, and execution of Automation Scripts/test plans and other QA project deliverables in support of application development. Identify, plan and participate in the delivery of process improvements.
- Oversee Risk Management activities including Failure Mode and Effects Analysis.
- Document required test data. Lead regular and reoccurring project defect reviews with the project delivery team.
- Run Investigation and RMA processes for discrepant materials.
- Support supplier qualification and monitoring.
- Review complex complaints or complaint trends and assist in the investigations.
- Available to be on calls in the morning or evening with global contract manufacturers and suppliers in other time zones.
- BS or MS degree in Mechanical/Electrical/Industrial Engineering.
- At least 5 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.
- 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.
- Ability to travel 10% domestically and internationally as needed.
- 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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