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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 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.
Demonstrated project management skills, 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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