Description
The SeniorQuality Engineer will report to the AssociateDirector of Quality.Responsibilities
* Participate in quality engineering activities in product development, manufacturing, and service
* Develop and maintain quality planning and cost of quality
* Provide guidance to affect adherence to Quality System Requirements
* Participate in engineering design review, verification/ validation activities
* Perform CAPA (Corrective Action Preventive Action) activities
* Provide technical expertise in root cause analysis and statistical techniques
* Perform/participate in internal audits
* Develop product quality plans
* Participate in the risk management process
Required Knowledge/Skills, Education, and Experience
* Bachelor of Science degree in Biomedical, Electrical or Mechanical Engineering
* Minimum of 3 years working in an engineering environment in the medical device industry
* Experience with FDA (QSR), ISO 13485, and MDD
* Proven interpersonal skills, ability to interact effectively with a variety of levels within the organization
Preferred Knowledge/Skills, Education, and Experience
Demonstrated experience with some or all of the following:
* Design controls, design verification and validation activities
* Production and process controls
* Risk management
* CAPAs
* Understanding of product quality improvement using tools such as Six Sigma
* Effective oral and written communication skills
To find out more about Real please visit www.realstaffing.com