Engineer

Thousand Oaks, California 91320 | Contract

Post Date: 01/31/2018 Job ID: 3816 Industry: Biotech

Description:

 

This position will provide quality engineering support for both new product development and sustaining to ensure design controls are followed in the creation of drug delivery devices in the Quality organization. 

The qualified candidate will employ quality principles and company’ s procedures to ensure development and sustaining of these mechanical and electro-mechanical medical devices complies with applicable regulations and standards. The Quality Engineer will work within cross-functional project teams to develop and maintain detailed engineering specifications, support device design & development, design verification/validation, to provide technical expertise and represent Quality functions and needs. 


Basic Qualifications: 

Master' s Degree 

OR 

Bachelor’ s degree and 3 years of Quality, Engineering or Operations experience 


Preferred Qualifications: 

BS in Engineering and previous experience in medical device industry 

3-5 years of Quality, Engineering or Operations experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience 

Experience with quality systems including: 21 CFR 820, Part 4 Combination Products, Medical Device Directives (MDD), ISO 13485 and ISO 14971 

Knowledge of Design Controls 

Experience with product design enhancements/improvements 

Experience in interacting with regulatory agencies 

Good written and verbal communication skills 

Ability to interpret and apply regulatory and quality requirements 

Ability to work independently as well as on teams 

Ability to prioritize and manage multiple tasks 

Ability to work in a challenging and fast-paced work environment

 
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