Job
Description
A Day in the Life In this role, this role will partner with Quality System team members to generate, analyze, communicate, and follow up with stakeholders to actions related to standard reports for the following QMS processes: -Periodic Review of QMS procedures -Training coming due and/or overdue notifications -Quality Data Analysis (QDA) In addition, this role will assist in the retrieval, review, and archival of Allograft Tissue Tracing Records. Responsibilities may include the following and other duties may be assigned: Communicates and collaborates with internal stakeholders such as Quality, R&D, Regulatory, Operations, Service and Repair, Supplier Quality, Procurement, Operations Quality, and Program Management Office across the following CST QMS entities: o Boxborough o Caesarea o Fort Worth CSF o Fort Worth MPSS o Lafayette o Memphis Pyramid o Memphis SGT Generates and analyzes standard reports (e.g., Periodic Review, Training and Quality Data Analysis) for compliance with KPIs, identification of patterns of underperformance to KPIs Communicates coming due and/or overdue notifications for Training and Periodic Reviews to affected personnel, their management, and Quality leadership Coordinates with internal stakeholders to implement corrections to Agile MAP with regards to Document and Process Owners Coordinates with internal stakeholders to implement corrections to Cornerstone with regards to removal of unnecessary trainings Coordinates with Quality System Program Manager on the generation of standard reports for QDA, preparation of presentations, coordination with data providers and reviewers, and processing of records within Agile MAP Required Knowledge and Experience Bachelor degree; Engineering or Science degrees preferred 3+ years quality assurance experience in medical or pharmaceutical industry Familiarity with medical device Quality Management System requirements (e.g., US 21 CFR Part 820, ISO 13485:2016, Regulation (EU) 2017/745) Experience running data queries and reports in software applications Strong verbal and written communication skills and ability to work in a team oriented environment Agile PLM knowledge/experience Ability to work independently once trained Ability to be proactive and lead initiatives Ability to multitask. About Medtronic We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here
