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In this role, you have the opportunity to

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

• BA/BS Degree

• 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?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .

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