EU MDR Quality Engineer

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Job Title
EU MDR Quality Engineer

Job Description

The EU MDR Quality Engineer is responsible for ensuring importer and distributor obligations for EU Medical Device Regulation (MDR) verification are fulfilled all over Europe and Turkey, by performing and/or supervising EU MDR verification activities and/or inspectors while content owning EU MDR verification procedures. The role properly escalates issues found during EU MDR verification, monitoring their follow up, and continuously improves the EU MDR verification process in Philips. The EU MDR Quality Engineer is also responsible for performing and supervising inspection of incoming medical devices in Spain, according to local Spanish legislation.

You will be part of the Patient Safety & Quality team in Europe and will be reporting to the Head of Quality Operations Europe.

You are the right fit if;
* Master's degree in quality management, Supply Chain Management, Engineering, Science or equivalent majors.
* Minimum 3 years in a similar role in medical device or pharmaceutical quality department.
* Previous active role in regulators inspections is a strong asset.
* Experience in leading internal audit processes is preferred.
* Previous experience in dealing with internal commercial stakeholders.
* Previous experience in dealing with stakeholders from all over the world.
* Fluent in English in addition to local Spanish language.

Preferred Skills:
* Strong attention to details
* Compliance mindset (meet requirements, collaborate with regulators and maintain accurate records and procedures)
* Communication and negotiation skills with colleagues from multiple backgrounds
* Ability to understand complex text and to go to the core of complex processes
* Quality Assurance (QA)
* Quality Management Systems (QMS)
* Continuous Improvement
* Quality Control Inspection
* KPI Monitoring and Reporting
* Auditing Techniques
* Regulatory Requirements
* Logistics & Distribution Compliance
* CAPA Methodologies
* Business Acumen

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company's facilities.
Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
this role is an office/role.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
* Learn more about our business.
* Discover our rich and exciting history.
* Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.

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