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Senior Quality Engineer

Employer
Perkin Elmer
Location
Santa Clara CA US
Closing date
Jun 15, 2017
About Us:
The Medical Imaging business of PerkinElmer is a global leader of high performance X-ray detectors with more than 25 years of experience.  The business has supplied over 35,000 detectors globally for use in medical, veterinary, and industrial non-destructive testing (NDT) applications.


We are seeking Senior Quality Engineer based in Santa Clara, CA.

Position Overview
This role is a critical member of the quality team and will interface with cross-functional team members to define and ensure the fulfillment of fundamental requirements in the development, and launch of new products and design improvements to existing products.  This role will support the project from concept to specification development and review, verification and validation activities, pre-production build through transfer to Manufacturing.

Specific Duties and Responsibilities
 
 
  • Supports interdisciplinary product development team to ensure design/development procedures, design controls, supplier controls and test requirements are conducted in compliance with applicable standards and that they are fulfilled.
  • Works cross functionally with R&D/Engineering and provides expert guidance in the review of technical documentation
  • Provides guidance with Product Development Manufacturing Engineering in development of process validation protocols and implementation of effective process controls
  • Leads and provides guidance for sourced component/material qualification activities and supports supplier risk management initiatives
  • Leads and provides guidance for root cause analysis investigations and product risk assessment.
  • Adheres to all safety and quality requirements including:  Quality Management Systems (QMS), U.S. Food and Drug Administration (FDA), Company policies and procedures and other regulatory requirements.

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