PMS and Sustaining Engineer

Job Description

Job Title PMS and Sustaining Engineer Job Description 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.