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A Quality Engineering opportunity with one of Stryker's newest and most innovative divisions.
This person will be doing hands on troubelshooting with cutting edge Neurovascular products. Will be primarily responsible for Product Complaint Investigations and for ensuring supplier quality. This position will also support the product development side on an as needed basis.
Qualifications/Work Experience
•Strong written/verbal communication skills. •Demonstrated used of Quality tools/methodologies. •Experience in FMEA, root cause analysis, and troubleshooting in the medical device industry is required. •Experience with catheters or similar products is preferred. •Participate and aid in the new product development process by identifying effective test methods. •Perform engineering risk analyses to manage technical difficulties encountered with new medical devices. •Verify that new engineering devices are technically sound and in compliance with FDA and other regulatory bodies. •Select, analyze, design and improve mechanical manufacturing procedures and engineering systems for medical devices. •Knowledge of applicable domestic and international regulations and standards (QSR,MDD,13485 and CMDCAS). •Analyzes reports and/or returned products and recommends corrective action. •May interact with customers to solve reliability issues and/or answer general product questions. •May work from verbal and/or written instructions. •May train others in quality assurance/GMP related topics. •Develop and execute process and product protocol.
Education and/or Special Training
•5-10 Years experience with BA/BS in Quality Engineering or related discipline.
The opportunity number you have entered is either no longer available or does not exist. You can use the job search box below to find other jobs matching your desired criteria.
