Quality Engineer III

ID# DCNJ24192

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

Job Description: 

The Staff Quality Engineer will work closely with R&D and Operations utilizing various Quality Engineering tools in the development and manufacture of innovative new products as well the maintenance of current products, materials and processes. This individual will function as a quality lead on multi-functional product development teams in matters relating to Quality Engineering. Will support design control and process validation activities for new and change product efforts. This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans. This individual will lead and ensure the development of comprehensive risk management plans for the product and process. The Staff Quality Engineer will ensure effective and comprehensive quality strategies. Will ensure the development and validation of appropriate test methods for design and manufacture of products and components. Will assist in thorough investigation of quality issues and effective corrective and/or preventive action. This Staff Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.

Qualifications 

  • A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is preferred. 
  • A minimum of 7 years of Quality Engineering work experience in medical device or other highly regulated industry is required, with ASQ certification (CQE, CQM, CRE or CQA). 
  • Knowledge of ISO and/or cGMP regulations is required. 
  • New product development experience is required, with experience in an FDA regulated environment. 
  • Supplier Quality Engineering experience is an asset. 
  • Strong knowledge in Quality Systems Regulations (QSR) preferred. 
  • Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is highly desired. 
  • Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required. 
  • Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs. 

 

Will ensure the development and validation of appropriate test methods for design and manufacture of products and components. Will assist in thorough investigation of quality issues and effective corrective and/or preventive action. This Staff Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.

Position Details:

Medical Device

Engineering

Start Date: 
8-19-2013
End Date: 
12-31-2013

SOMERVILLE, NJ

CON_W2

40

DCNJ24192

No

No