Medtronic seeks a Quality System Specialist to 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. Key Responsibilities - 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. Requirements - 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. 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 passionate people.