Lab Equipment Validation Engineer

Title : Lab Equipment Validation Engineer

Location : Irvine CA

Contract : 6 months

Detailed scope of the project is listed below:

Must Have Should be well aware of 13485:2016 requirements

Validation and induction of all the existing laboratory equipment as part of the laboratory master validation plan (MVP)

o There are several pieces of equipment in Edwards materials lab needing validation/qualification that includes performing feasibility/development IQ protocol IQ execution/report software validation (if applicable) for the equipment in scope.

o Tasks also include the induction of the validated equipment into Edwards asset management system

o Coordinate with Metrology team for the calibration of the validated equipment.

Materials Science Supplier Notification of Change (NOC) management and validation.

o Work with supplier quality engineering and suppliers to assess NOC change impact validation & regulatory strategy and execute.

o Support the NOC qualification of materials and components

o Assist engineering staff in the design authorship execution and closure of protocols supporting the qualification of materials and components

Execute textile testing protocols to support NOCs

o Support in executing the textile testing protocols according to ASTM and internal test methods utilizing equipment located in the Materials Science Laboratory

o Generate reports to support product qualification activities

Assist engineering staff in the design authorship execution and closure of protocols supporting the qualification of materials and components