Quality Engineer III
A10 - Somerville, NJ

This job posting is no longer available on A10. Find similar jobs: Quality Engineer jobs

Location :
SOMERVILLE, NJ

Position Type : Contract

Experience Level :
Start Date / End Date : 01/21/2013 / 12/31/2013

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 ( 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.

.

A10 - 17 months ago - save job - block
Recommended Jobs
Director, Quality Assurance
Sirius XM Radio - Lawrenceville, NJ
Sirius XM Radio - 4 days ago

Quality and Reliability Engineer
Verizon - Basking Ridge, NJ
Verizon - 7 days ago

Quality Manager II
A10 - Skillman, NJ
A10 - 15 hours ago