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HC - Quality Engineer 3 - 9999NE - 100214
Ref No.: 17-15645
Location: Brookfield, Connecticut
Start Date / End Date: 05/08/2017 to 03/30/2018
Quality Engineer needed to Assist in Validations and maintain validation review boards as well assist in decommissioning activities.

The Quality Engineer III will be responsible for providing support to the New Product Development activities. In this role he/she will interface with R&D, Engineering and Operations to ensure the successful transfer to Production of new products in accordance with approved processes. The activities include leading validation reviews, driving quality changes, in validation activities and change management .

Additional responsibilities include:
1.) Lead Review and feedback sessions of validation protocols and change documents.

2)Review and approval of non-conformances, ensuring prompt resolution of issues and continuous supply of material/components.
3)Analyze failure, corrective and preventive action submitted by suppliers for adequacy.
4)Gathering and analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel. Preparation of QA reports.
5)Assist Quality manager in establishing, implementing and maintaining the quality management system.
6)Provide support during audits.
7)Support test method validation and gage R&R studies.


Requirements:

Education: BS/BA in Engineering (or advanced degree) or equivalent combination of education and experience.
Experience working directly with suppliers to ensure quality of incoming materials/components, preferably in an ISO 13485/ QSR regulated environment.
Experienced in Geometric Dimensioning & Tolerancing (GD&T), preferred.