Establish compliance design requirements for ARIS QMS Portal implementation and supports deployment activities to business and markets in alignment with the established blueprint.
You are responsible for
Influence the compliance related design requirements for the ARIS QMS Portal Blueprint ensuring compliance with round-the-world medical device regulations
Represent the ARIS QMS Portal design in internal and external regulatory reviews, audits and inspections
Provides ARIS portal leadership and coaching in deployments to businesses
Set minimum Readiness Requirements (inc PEPFs that must be deployed) as part of local ARIS QMS Portal deployment
Defines QMS Org design and capability requirements to support ongoing maintenance of local ARIS QMS deployment
Support MS/QMS ARIS Portal deployments as part of PQMS strategy
Supports with the BPM CoE ensuring ARIS QMS Portal is operated with the proper change control
Interface with Business Process Management CoE in aligning on compliance design requirements needed to support ARIS QMS Portal blueprint
Solves problems using LEAN techniques in a structured manner to get to root causes and develop clear actions plans to effectively eliminate or mitigate the risk. This includes conducting a logical analysis of the situation or data taking into consideration organizational objectives.
Partner with business stakeholders to realize the implementation of ARIS QMS Portal deployments
To succeed in this role, you should have the following skills and experience
5 years of related experience with demonstrated technical leadership
Computer Systems Validation
In depth knowledge of external regulations (e.g. FDA/ISO)
Quality Systems Management (e.g. ISO 13485)
Manage complexities in a multi-disciplinary setting
Systems Engineering expertise
Innovative in the application of quality system design principles while promoting standardization
Able to identify best practices and create and influence stakeholder buy-in to leverage these in the promotion of continuous improvement
Problem solving skills with particular emphasis on LEAN techniques
Expertise designing and setting up ARIS for use in a QMS medical device environment preferred
Why should you join Philips?
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