Job Description
Job TitlePMS 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.