Quality Systems Specialist-1.

Job description

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the LifeAs a Quality Systems Specialist, you will serve as an independent quality representative supporting regulated IT projects across the organization. You will review validation and lifecycle documentation, provide guidance to project teams, assess compliance risks, and help ensure technology solutions are implemented in accordance with quality and regulatory requirements. This role offers exposure to a broad portfolio of technologies, including cloud solutions, data platforms, automation, and emerging digital initiatives. This position is based in Bogotá, Colombia and follows a flexwork model. Responsibilities may include the following and other duties may be assigned: ·        Review and assess validation deliverables, testing documentation, risk assessments, and system lifecycle records for regulated IT solutions ·        Provide quality and validation guidance to project teams throughout planning, execution, and implementation activities ·        Evaluate project documentation to ensure alignment with quality processes, regulatory requirements, and internal standards ·        Partner with global stakeholders to support the implementation of compliant IT systems and processes. ·        Assess requirements, testing evidence, and risk management activities to verify readiness for system deployment ·        Support audit readiness activities, corrective and preventive action (CAPA) investigations, supplier quality initiatives, and regulatory assessments as needed ·        Contribute to continuous improvement initiatives that strengthen quality, compliance, and validation practices ·        Collaborate with cross-functional teams across multiple regions within a global virtual environment Required Qualifications ·        Bachelor's degree and 2+ years of experience in quality, compliance, validation, or regulated environments such as medical devices, pharmaceuticals, life sciences, manufacturing, or related regulated industries ·        Experience reviewing, executing, or approving validation deliverables for regulated systems ·        Experience supporting validation activities throughout the regulated IT system lifecycle ·        Knowledge of validation lifecycle methodologies and risk-based validation principles ·        Advanced English proficiency with the ability to collaborate effectively with global stakeholders Preferred Qualifications ·        Experience within the medical device, pharmaceutical, or broader life sciences industry ·        Knowledge of ISO 13485, FDA 21 CFR Part 11, and European Union Annex 11 regulations ·        Experience supporting global project teams in a virtual, cross-functional environment ·        Experience with audit support, CAPA processes, supplier quality activities, or regulatory reviews ·        Project management experience and ability to present recommendations to stakeholders and leadership 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. ‌ ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com. Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. ‌ This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).