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.
APN Software Service INC