EU MDR Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title
EU MDR Quality EngineerJob 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;
Masters 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 companys facilities.
Field roles are most effectively done outside of the companys 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 wont 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 youre 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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Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
