Philips QMS Project Leader - Philips Image Guided Therapy Systems IGTS 

Germany, Hesse 

418232333

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 14971.

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.

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