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Job TitleQMS Software Validation Engineer - Philips - Drachten
Job Description

Your Role

Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW application, which automate Quality System processes.
Authors, reviews and/or approves SW validation deliverables for non- product SW, including but not limited to SW Quality System Impact Assessments, validation plans, requirement test plans/protocols/results, risk assessments and summary reports.
Support external regulatory assessments and internal audits by providing validation documentation and subject matter expertise.
Facilitate the application of controls and risk management by reviewing and approving change-control requests to assess potential quality system impact.
Contribute SDLM learnings and best practices to advance departmental methods.
Maintain communication with project management and/or IT teams to ensure understanding of schedule commitments, actual schedule durations, anticipated scope changes and project risks associated with validation activities.
Support the project team during test execution to ensure compliance and assist in documenting deviations.
Support updating the processes relating to Non-product System Software Validation.
Works autonomously within established procedures and practices.


You're the right fit if:

At least a bachelors degree in an engineering or scientific-related field or other plus equivalent technical experience working in a medical device environment.
Experience: at least 3 - 5 years of QMS management experience in medical device, consumer products industry or food contact material industry.
Practical experience with IT Software Validation methodology in regulated medical device and healthcare industry.
Strong understanding of appropriate global regulations, requirements, and standards such as FDA 21CFR Part 820/Part 11, ISO 13485 and ISO 9001.
Able to understand and analyze complex problems.
Strong planning, communication, presentation skills, people management, leadership qualities and Project Management skills, including ability to project manage Non-Product System Software Validation activities.
Experience in Change Management.
Strong reasoning and logical thinking skills.


In return, we offer you
A path towards a most rewarding career. Philips is growing its capability enterprise wide. Succeeding in this role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.


Please note: For this position we do not offer relocation support.



Recruitment Process

If you are interested in this opportunity to join us, please read the complete job description on our website and upload your
resume and motivation letter
through the Philips career site- vacancy number
519995.



Please note that the closing date of this vacancy is Wednesday, 3 April 2024.





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 here
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Discover our rich and exciting history here
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Learn more about our purpose here
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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 commitment to diversity and inclusion here.

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