QMS Validation Manager

Job Title - Quality Validation Manager 
 
Job Location – Bothell WA
 
Length – Contract (12 Months+)

 In this role, you have the opportunity to 
 Help build a high growth business that will help improve the lives of millions of people while advancing Philips journey as a global leader in Health Technology. 
 
You are responsible for
o Establish lean practices around Quality System Software Controls for all shared or local QMS SW systems in line applicable policies and procedures 
 o Ensure that software applications and related infrastructures are validated for their intended use by a controlled and documented process 
 o Ensure that new software and changes to existing software or infrastructures are validated before approval and use 
 o Ensure documentation of SW validation activities and results for all phases of the software system Life cycle. 
 To succeed in this role, you should have the following skills and experience 
 o Understanding of current inspection practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections 
 o Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained. 
 o Effective judgment and decision making skills, typically made under stressful situations. 
 o Competency in project management and the execution of multiple projects. 
 o Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com

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