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QMS Manager

Posted Sep 23, 2019
Project ID: PHILJP00020655
Eindhoven , Noord Brabant
6 months
(Oct 1, 2019 - Mar 31, 2020)
40 hrs/week
Payrate range
QMS manager

In this role, you have the opportunity to
Guide and support sites within the non-medical Quality Management Systems (QMS) of Personal Health and enabling functions to always do the right thing. As a QMS (Quality Management System) Manager within the PQMS (Philips QMS) Personal Health Team, you will drive QMS compliance during the Quality “Accelerate” Transition program; ensure that QMS processes comply with regulations. You will secure that the QMS is consistent and check the effectiveness of the QMS processes. You will manage a team of about 8 people in a cross functional, multicultural and global setting.

You are responsible for
•   Maintains, enforces, and manages a compliant and effective Personal Health non-medical QMS across different sites
•   Maintains an effective and lean QMS structure
•   Chairs the Change Control Board and interacts with change requesters and Business Process Owners
•   Manages transition of E2E programs into the QMS, while maintaining compliance and effectiveness throughout the duration of the transition to the QMS
•   Ensures traceability between Philips global processes and the QMS
•   Acts as the Business Process Expect for Integrated Change Control
•   Prepares and presents the Management Review
•   Chairs the CAPA Review Board and interacts with the CAPA Facilitators from each site
•   Drives the TEDS Training Administrators Network and manages the KPI around training compliance

You are a part of
The Personal Health Central Team plans, controls and manages relevant QMS activities for all InD sites within Philips Personal Health for the Non-medical portfolio, catering to Kitchen Appliances, Home Care, Garment Care, Coffee, Beauty, Male Grooming, Mother and Childcare, Oral Healthcare.

To succeed in this role, you should have the following skills and experience
•   Bachelor or Master with at least 7 years of experience in Quality Management Systems.
•   Experience in a highly regulated environment (Medical Device, Pharma, Automotive, Aerospace, Food contact)
•   Negotiation and influencing skills
•   Planning skills within the QMS and multi-disciplinary teams
•   Problem management (finding and driving to resolutions)
•   Strong communication skills (translating QMS requirements to engineering language)
•   People management experience of a team in a cross functional, multicultural and global setting
•   Practical implementation and audit management understanding of ISO 9001/13485 standards, US FDA and EU MDR requirements is a must. (this will help to drive decisions around deployments, audits, etc. )
•   Comfortable with constant change
•   Able to keep many balls in the air at the same time while keeping the overview (stakeholder management)
•   Project management experience is preferred
•   Independent worker and hands-on mentality
•   Highly proficient in spoken and written English

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