Principal Quality Engineer/External Finished Goods

The Principal Quality Engineer will:

 

* work closely with External Finished Goods manufacturers to ensure product quality meets companies requirements,
*  provide in depth process quality engineering support with respect to process validation activities as well as post launch supplier quality tasks including manufacturing issue resolution,

* work closely with the product development groups to ensure product specifications (including Systems and SWRS) are appropriately translated into manufacturing documentation. Work closely with EFG suppliers to identify testing and analysis required to ensure specification conformance,

* perform EFG supplier assessments via auditing and reporting,

* perform product, process and system audits as required. Manage audit and supplier corrective actions, implementation and effectively,
* apply risk assessments, product reliability methods (HALT/HASS) to ensure product meets functional and safety requirements, and
* review/approve technical instructions (DFU,IFU's) for compliance to internal and external requirements.

Education and Experience:


BS in Mechanical/Manufacturing Engineering or other Technical discipline is required. Masters degree is a plus.

Must have excellent communication and interpersonal skills
Ability to manage multiple projects with a proven track methods of meeting deadlines.

Ability to develop strong cross-functional relationships

Knowledge of QSR and FDA design/process control requirements is required.

Working knowledge of ISO requirements and the MDD are essential.
9 plus years of experience in the medical device industry with 2-4 years of medical device auditing experience with an emphasis on product auditing.
Strong analytical skills with the application of statistical methods resulting from Risk Analysis is required.
2D/3D modeling knowledge a plus.