Quality Engineer III

Carlsbad  ‐ Onsite
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Keywords

Description

Job Description

Position Overview
The Quality Engineer will report to the Sr. Manager of Quality in the Knoxville facility. The QE is responsible for quality engineering activities through participation in the product development phase through commercialization and sustaining. As a member of a cross-functional team, the QE ensures quality objectives are met which are consistent with regulatory requirements and business objectives.
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
Start date
07/2013
Duration
6 months
From
Real Staffing
Published at
04.07.2013
Project ID:
561457
Contract type
Freelance
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