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In this role, you have the opportunity to

Assess the effectiveness of the EU MDR Market Verification process, and the compliance of that business process with Philips and EU regulatory requirements. You will also be supporting the Markets Supply Chain with a variety of activities to ensure compliance to applicable standards and regulations.

You are responsible for

• Auditing against the EU MDR Market Verification process end to end, and leading quality-related problem solving and root cause analysis

• Plan, coordinate, and execute audits to assess the compliance and effectiveness of the overall EU MDR verification process from Market all the way back to the Business unit

• Review responses to audit findings for completeness and effectiveness

• Identify at-risk businesses in need of compliance support through the monitoring of actions and the assessment of compliance data, and assist organizational units in addressing compliance deficiencies

• Use post-market analytics and statistics to report on process/product issues and feed back to the audit management and process stakeholders

• May also provide quality engineering support, including assisting organizations in leading quality-related problem solving and root cause analysis, setting up sampling plans and writing quality engineering reports

You are a part of

The Markets Supply Chain Quality & Regulatory department, supporting the EU MDR Market Verification process.

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree

• 5+ years of relevant experience in a Medical Device, Pharma or other regulated industry

• Working knowledge of appropriate global medical device regulations, requirements, and standards, such as EU Medical Devices Regulation (EU 2017/745), 21 CFR 820, ISO13485, ISO14791, and ISO9001

• Audit training/experience

• Strong CAPA knowledge and experience

• Strong IT skills, including but not limited to MS Office (advanced user), SAP ERP, Business Objects

• Excellent communication skills, in verbal and written English

• Able and willing to travel internationally up to 35% of the time

In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:

• A market conform salary

• 25 Days of leave and the possibility to purchase up to 20 extra days off annually

• A variable bonus based on both Philips results and personal performance

• Extensive set of tools to drive your career, such as a personal development budget, free training and coaching

• Solid company pension scheme and attractive collective health insurance package

• Opportunity to buy Philips shares and products with discount

• Healthy work-life balance

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. Learn more by watching this video .

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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