Take part in the transformation journey towards a world class Operations organization to better serve our customers with speed and excellence. You will be a part of the Factory Best organization, which is one of the main Operation sites for Health Systems within Philips. Our Factory Best organization is driving operational excellence and manufactures, refurbishes and repairs 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.
You are responsible for
New Product Introduction, 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. You also ensure that the execution of the process meets the requirements as stated in the validation life cycle process
Mentor and coach managers/engineers on the validation life cycle process
Participate in design transfer activities such as review of Device Master Record, DFMEA, manufacturing design and Process FMEA
Responsible to establish and maintain 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.
You ensure 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. The Quality department for Factory Best reports into the Q&R. The Quality department focuses on ensuring product quality, while maintaining full compliancy and driving manufacturing excellence. The aim is to achieve timely releases of products with high quality and outstanding reliability.
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
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
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
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.
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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