Quality Engineer - Medical Device 8/19/2016
JOB DESCRIPTIONAPPLY Established medical device company operating in over 20 locations worldwide is seeking several QualityEngineers. With annual sales of over $3.5 billion, they have more than 50 years of leadership in endovascular therapy.
The QualityEngineer is responsible for recognizing and implementing improvements to products and manufacturing processes that result in producing a high quality products.
* Proactively investigates, identifies, and implements best-in-class QualityEngineering practices.
* Execute of assigned project development activities.
* Establish effective corrective action plans.
* Develop product/process assurance plans. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed requirements
* Developing and implementing strategic quality plans, master validation plans, validation protocols, inspection plans and procedures to meet regulatory requirements.
* Monitor product quality data to identify negative trends and initiate mitigating action.
* Requires a minimum of a 4 yeardegree in engineering, life sciences, or similar.
* Requires three to ten years experience in a medical device environment.
* Preferably two years of auditor experience.
* Preferably certification as a CQA, CQE, or CQM.
* Strong writing, mathematics and statistics skills
** DISPOSABLE MEDICAL DEVICE EXPERIENCE IS A PLUS!**