Quality System Manager
In this role, you have the opportunity to:
In this role, you have the opportunity to drive progress on QMS Improvement and Maintenance, including active support and ownership of department CAPAs.
You are responsible for
- Drive progress on QMS Improvement and Maintenance, including active support and ownership of department CAPAs
- Ensure compliant and effective QMS is maintained in scope
- Support the move toward the Philips Excellence Process Framework for the transformation of all current QMS parts in scope toward the PQMS structure
- Accountable to standardize all QMS management processes and ensure the FDA-compliant validation of all SW systems in scope
- Supports local Q&R processes and ensures local process ownership for all activities under the PQMS governance in scope
- Validates Q&R requirements are effective in all processes in scope; monitors process performance
- Ensures Document Control is established and ensures training profiles are assigned and enforced and training administration is established within scope; processes Engineering Changes.
- Other duties as assigned
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree plus a minimum of five (5) years’ of similar work experience
- Experience working in disciplined regulated industry and in applying automated technology (i.e. software tools)
- Experience in corrective and preventive actions, including root cause analysis, documenting findings/actions, and implementing actions.
- Experience validating activities for applications
- Business application implementation projects including being an active contributor on projects with scheduled deliverables.
- Ability to understand and develop processes
- Demonstrated ability to interact and communicate in English, including writing, speaking and comprehension skills; ability to communicate across levels of the organization.
- Lean and six sigma experience is a plus
- Travel up to 15%
Why should you join Philips?
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