Designated by the Head of Q&R Image Chain to ensure compliance to worldwide regulatory requirements for Image Chain products
Independently produces and completes Quality Engineering documents
Responsible for performing timely, quality engineering tasks like: assessing quality plans, assess product designs and reviewing test and other performance data
Independently defining quality and regulatory requirements for the product within the design process
Responsible for assessing and approval of design related activities for the life cycle management process
Leading V&V activities together with test and integration to provide certification submittal packages
Review and manage Software tool validation records
Support Q&R activities related to QMS requirements (review of design documents, which are part of PDLM procedures)
Key player for risk management (safety) activities for product development
Responsible for performing timely, detailed CAPA engineering tasks like: assessing issue descriptions, reviewing CAPA data sources, assisting with root cause analysis and quality problem solving
You are a part of
our Q&R Image Chain team, which is responsible to establish and maintain product quality. This includes managing the quality and regulatory documentation for the products to ensure compliance and product quality.
To succeed in this role, you should have the following skills and experience
Degree in electrical engineering or mechanical engineering or similar
Professional knowledge in the area of regulatory affairs FDA / MDR
Professional knowledge in the area of product related safety standards (IEC, CSA)
Professional knowledge in the area of ISO 13485 / FDA 820 / ISO 17025 is a plus
Readiness of mind, analytical thinking, quick familiarization with new working areas
Open minded to working in a culture of continuous change
Strong communication skills in German and English and acting as business partner
Flexibility and team orientation
Knowledge in MS Office, SAP, Windchill is a plus
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 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.