Brookfield Connecticut USA 06804
12 months extendable contract with potential to convert fulltime
The Quality Engineer-3 will be responsible for providing support to the quality organization. In this role/he/she may interface with R&D, Engineering, procurement and Operations to ensure the successful processing of all quality related activities. The activities may include leading validation reviews, driving quality changes in validation activities and change management, processing nonconforming material in SAP quality notifications module.
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 analyzing of quality data for trending purposes using software tools such as Minitab and Microsoft Excel. Preparation of QA reports as directed by Sr. QA Manager.
5) Assist Quality Manager in establishing, implementing and maintaining the quality management system.
6) Provide support during internal and external audits.
7) Support test method validation and gage R&R studies
***Preference will be given to candidates with experience in an ISO 13485/QSR regulated environment, processing nonconforming material, validation and auditor certification and experience.
Education: BS/BA in Engineering (or advanced degree) or equivalent combination of education and experience.