Pune, IND
22 hours ago
PMS and Sustaining Engineer
Be part of a fast-growing business that helps improve the lives of millions of people. Being part of the PMS team of MR will allow you to work with cross-functional teams to ensure proper monitoring, collection, and analysis of information and establishment of actions on distributed products to guarantee patient safety, product quality, and customer satisfaction. **Your role:** + Organizing the collection of all information needed to create PMS plans, reports, and periodic quality reviews. + Facilitating the creation of PMS plans, reports, and periodic quality reviews by written procedures and applicable global requirements, by working with a variety of diverse persons within MR Systems such as Designers, Marketing specialists, Scientists, Service & Application Engineers, and Manufacturing. + Reviewing and approving PMS plans and reports. + Supporting the identification of metrics on the efficacy and efficiency of PMS activities and monitoring and reporting on those metrics. + Collaborating in the preparation of regulatory inquiries related to products manufactured in Pune. + Supporting audit/inspections of MR products manufactured in Pune. + Being the PMS process expert in Pune. **You're the right fit if:** (4 x bullets max) + Bachelor’s degree in biomedical engineering, science, healthcare, or medical profession. + 10+ years’ experience in Quality in Medical Devices and/or other regulated industries preferably in Risk Management, Correction and Removal/Recalls, Complaint Handling, or PMS. + Focus on detail. + You have a statistical background and good knowledge of Excel. + You have experience in Project management (preferred) + You are fluent in English (verbal and written). + Good analytical skills and process improvement capabilities + Teamwork in and outside Q&R. + Strong written and oral communication skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers). + High degree of initiative, engagement, self-motivation, and flexibility. + Able to work in a changing environment and be a driver of change. + Product Knowledge is preferred.
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