Medtronic Bogota, D. C. Capital District, Colombia Join or sign in to find your next job Join to apply for the Quality System Specialist role at Medtronic Medtronic Bogota, D. C. Capital District, Colombia Join to apply for the Quality System Specialist role at Medtronic At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Medtronic is among the largest medical technology companies in the world. Through innovation and collaboration, Medtronic helps to alleviate pain, restore health, and extend life. Last year, our medical therapies for the treatment of over 40 major conditions, improved the lives of more than 75 million people around the world. The Quality Systems Specialist support Americas Customer Care and Order Operations Quality based on the Strategic Workforce Planning and Quality strategy for LATAM and Canada. This role is remote based in Colombia. Responsibilities may include the following and other duties may be assigned: Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external Co-ordinate legal requests in support of government investigations or litigations Ensure the quality assurance programs and policies are maintained and modified regularly Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally Required Knowledge and Experience: Bachelor’s degree Three years of work experience in quality role, regulatory affairs within pharma or medical devices industry Fluent in English Expertise in CAPA compliance & investigation techniques Knowledge with ISO 9001: 2015 and ISO 13485:2016 Knowledge with Power BI and Auditing experience is advantageous. Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. Benefits & Compensation Medtronic offers a