Philips Quality Manager 

Netherlands, North Brabant 

827497831

Quality ManagerJob Description

In this position you will review new or existing QMS processes to ensure they are compliant, and that the impact of changes across all International Region is clear, agreed, and documented. You will also drive improvements and management reviews, in such a way as to ensure that the Business strategic policy and strategic growth targets are met.
Your role:

• Support the MS-QMS Owner and the Management Representative in defining the MS-QMS Strategy

• Monitor the progress of MS-QMS Planning and related activities

• Secure adherence to MS-QMS processes and procedures

• Determine PEPF version release (global content updates) plans

• Manage Intracompany Quality Agreements (ICQA)

• Manage certification of the MS-QMS (when applicable) and liaise with Certification Partners as needed including reporting Substantial changes to the MS-QMS

• Assess MS-QMS Risks and Opportunities

• Assemble relevant reports and data for input to Management Review

• Provide guidance for documented information retention and archival for regulatory compliance and/or business reasons.

You're the right fit if:

• You have in-depth knowledge of ISO 13485 and of its practical application.

• You have been involved with an active role in FDA inspections.

• You are able to read complex text and go to the core of complex processes.

• You have experience in dealing with commercial stakeholders.

• You have experience with stakeholders from all over the world.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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