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Philips

Change Control Specialist

Posted Mar 13, 2020
Project ID: PHILJP00016255
Location
Eindhoven, Noord Brabant
Hours/week
40 hrs/week
Timeline
11 months
Starts: Feb 1, 2018
Ends: Dec 31, 2018
Payrate range
72 - 82 €/hr
Functie = Change Control Specialist
Omschrijving = zie bijlage
must have item = Business Process Expert (in the area of QMS Change control)
nice to have items = Project management
Budget = max. 82 euro


Your challenge
We are looking for an enthusiastic contingent worker in the area of Change, Document and Record control with experience in Business Quality Management Systems (ISO 9001 / ISO 13485) and FDA (21CFR) regulations within an international environment?
Your responsibilities
 Leads and supports lower level Document Control Specialists.
 Effective (local) Business Process Expert role for Document Control processes and tools in scope.
 Establishes Document & Record support to authors and (local) process owners in defining and producing lean Quality System documents and records; ensure proper quality of the content of documentation and records
 Leads and supports (global) authors of controlled documents to be lean, well accessible, easy to maintain and according to the agreed look and feel.
 Effective (local) Business Process Ownership/Expert role for Document Control processes and tools in scope
 Establish and manage proper document review processes
 Ensures availability/publishing of controlled documents
 Establish, monitor and respond to metrics on the efficacy and efficiency of the document management system and its ability to support the business
Your team
You are part of the Philips Q&R – PQMS capability and you will be part of the Center of Excellence – Controlled Documented Information (CoE CDI) team existing of 10 persons dealing with activities like Quality Management, System Validation, Training, CAPA, Management Review and Change, Document & Record Control.
Our offer
We welcome you to a challenging, innovative environment with great opportunities for you to explore. The offer will be based on a temporary contract (1 fte) till end of 2018.
We are looking for
Our ideal candidate has the following profile criteria:
 BA/BS degree.
 CMII certification (or other equivalent configuration management certification) preferred.
 6 Sigma/ LEAN certification preferred.
 Minimum of 6 years of related experience in change control and or document control field
 Familiarity with Document Management System tools
 Experience running effective process improvement projects
 Knowledge of Applicable regulations (Quality System Regulations) and regulatory requirements
 Strong focus on customer service
 Preferred Qualifications:
o Engineering background.
o Procedural or Technical writing experience.
o Understanding of modeling tools.
o Awareness of Project Management Institute standards.

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