Job Summary: We are seeking a Quality Systems 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 - Develop and maintain quality programs, systems, processes and procedures that ensure compliance with policies and 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 liaise with auditing groups and inspectors through all stages of the audits - Prepare reports and/or necessary documentation (e.g. Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external - Coordinate legal requests in support of government investigations or litigations - Maintain and modify regularly quality assurance programs and policies - Foster uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally 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 Benefits We offer a competitive salary and flexible benefits package. A commitment to our employees' lives is at the core of our values. We recognize their contributions. They share in the success they help to create. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). About Us We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. We have the talent, diverse perspectives, and guts to engineer the extraordinary.