QMS Project Leader
2 maanden geleden
As a QMS Project Leader at Philips IGTS, you will play a pivotal role in ensuring the compliance and success of quality projects within the Image Guided Therapy Systems business unit. Your responsibilities include overseeing the Quality Management System, supporting deployment of Philips Quality Management System and PIL solutions, and leading various QMS projects. This is a dynamic position that involves collaboration with cross-functional teams, managing the CAPA program, and contributing to continuous improvement initiatives. This position offers opportunities for professional growth, project management experience, and exposure to global medical device regulations. Hybrid working options are available, enhancing work-life balance.
Your Role:- Your role directly influences the compliance of the Quality Management System and the success of QMS projects crucial for the future of Philips IGTS.
- You develop and guide the overall governance & program management structure for initiatives/transformation/continuous improvement projects including operating plans and way of working using key project management tools (Risk Management Plan, Program/Project Plan, Schedule, Resource Plan, Daily Management, RACIs, etc.) to mitigate risks, provide clear direction and ensure execution.
- You ensure transformation/continuous improvement projects are delivered on time/budget and with the agreed-upon scope.
- You will be an integral part of the IGTS QMS Team, working closely with various departments and management levels to ensure project plans are supported and resources are available.
- Compliance of the Quality Management System, (QMS) with relevant standards and regulations and improving of quality system processes, documentation practices, and training.
- Assist in achieving continued Quality System Certification by supporting both internal and regulatory agency audits; including coordinating and participating in audits as needed.
- Bachelor's degree in a scientific or technical field with 6+ years of experience in the medical device industry.
- Strong working knowledge of global medical device regulations, including EUMDR, 21 CFR Parts 803, 806, and 820, ISO13485, and ISO
- Proven project management skills inherent to your nature, certification preferred
- Detail oriented, organized, and natural driver
- Experience in corrective and preventive actions, and the ability to troubleshoot complex process/system issues.
- Bachelor's degree in a scientific or technical field.
- Excellent communication, organizational, and analytical skills, along with a strong understanding of GMP's, GLP's, GDP, and FDA regulations.
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.
- Discover our rich and exciting history.
- Learn more about our purpose.
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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