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Job TitleProcess Quality Engineer
Job Description
In this role, you have the opportunity to

Take part in the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence.


You are responsible for

New Product Introduction projects, Life Cycle Management, and manufacturing location transfer projects to establish a robust manufacturing process to meet regulatory requirements for design transfer, process and tool validation.
Drive product quality targets such as First Pass Yield (FPY), product and process quality notifications (QNs)
Being in lead for establishment and completion of Receiving Inspection Plan (RIP)
Participate in design transfer and process design activities such as review of Device Master Record, DFMEA, manufacturing design and Process FMEA
Participation in standardization of processes, PEPF (Philips Excellence Process Framework)
Mentor and coach managers/engineers on design transfer, process design and the validation life cycle process
You support the process owner to define the validation life cycle process, by creating the procedure and templates. Once validation state is reached, it is maintained according to change process.
Youensure that the validation life cycle process meets regulatory and Quality Management System requirements (21CFR part 820.75, 820.70(i), 820.72(a), ISO 13485, and compliance with FDA guidance documents such as GHTF, etc).
Ensure the content of the process is consistent within the Quality Management System by review & approval
Ensure that the automated data processing systems and tools are validated against intended use and user need according to GAMP5 methodology
You accompany internal & external audits related to process validation, such as FDA, 3rd party and notified body audits and ensure initiation and follow up of corrective and preventive actions


You are a part of

The New Product Introduction (NPI) & Validation team, which is a part of Factory Best Quality department. We focus on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim isto achieve timely releases of products with high quality and outstanding reliability.
You will be a part of the Factory Best organization, which is one of the main Operation sites for Health Systems within Philips. We drive operational excellence and manufacture, refurbish and repair our medical devices & components in a safe, compliant, and effective manner.
The Factory Best team is also responsible for the preparation and introduction of changes on products/components/production processes for released products and receiving and implementing manufacturing transfers from Industrialization engineering.


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

Bachelor of Science degree in a technical or business discipline
Minimum 3 years of experience in a medically regulated and technical environment within a medical device company
Knowledge of manufacturing and design process and process FMEA, preferably experience in design and establishment of manufacturing processes, Design FMEA, DMR, Design for Assembly, manufacturability and testability
Excellent knowledge of medical device regulations 21CFR FDA parts 820.30(h), 820.75, 820.70(i), 820.72(a), 820.80 and ISO 13485 and guidance documents, knowledge of ISO14971
Statistical knowledge, particularly Gage R&R ANOVA, Attribute Analysis agreement and process capability such as PpK study, First Pass Yield
A good communicator on different organizational levels in English
Strongly preferred: proven experience in multi-site, multi-disciplinary quality organizations


In return, we offer you

We welcome you to a challenging, innovative environment with great opportunities for you to explore.


Why should you join Philips?

Working at Philips is more than a job. Its 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 its 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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