Quality System Specialist.

Medtronic plc; Bogotá ciudad; Híbrido; COP 60.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Medtronic plc recherche un Responsable du Système Qualité à Bogotá pour diriger les activités de vigilance et de conformité des dispositifs médicaux. Vous piloterez les processus de plaintes et de reporting réglementaire et soutiendrez les initiatives d’amélioration continue au sein d’un cadre QMS international.

Le poste nécessite un diplôme pertinent, une maîtrise de l’anglais, et une expérience en Post Market Surveillance, Vigilance ou QA/RA.

Formación

• Diplôme de niveau Bac+ dans les domaines médicaux/scientifiques ou ingénierie.

Responsabilidades

• Exécution des activités de gestion des plaintes: décisions réglementaires et reporting.
• Utiliser les outils du système de gestion des plaintes (Global Complaint Handling system).
• Assurer la clôture des rapports réglementaires après enquête de manière opportune et conforme.
• Répondre aux demandes des parties prenantes sur le statut des décisions et rapports réglementaires.
• Former le personnel sur les activités système, y compris plaintes, reporting et CAPA management.
• Suivre les échéances de reporting et soumettre les rapports en temps voulu aux autorités.
• Participer aux enquêtes CAPA pour identifier les causes profondes des écarts.
• Documenter CAPA et suivre les actions correctives dans le système.

Conocimientos

Fluent English

Educación

Bachelor's Degree en sciences (Medical/Biological/Pharmaceutical/Engineering)

Herramientas

MS Office Suite

Descripción del empleo

## Quality System Specialist.Postuler: Mode de travail Flexible Work Arrangement: Bogotá, Bogota, Colombia: Temps plein: Offre publiée aujourd'hui: Date de fin : 30 septembre 2026 (Il reste 7 jour(s) pour postuler): R77079Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.**Journée type****Responsibilities may include the following and other duties may be assigned:*** Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission)* Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system)* Ensure closure of regulatory reports with investigation are done timely, consistently and in compliance with regulatory requirements.* Respond to stakeholder inquiries regarding status of regulatory decisions and reports* Assist in training new personnel on system activities, including complaint handling, regulatory reporting, and CAPA management* Monitor regulatory reporting deadlines and ensure all reports are submitted on time to relevant authorities* Review and verify the accuracy and completeness of regulatory reports before submission* Participate in CAPA investigations to identify root causes of quality issues and deviations* Perform activities within the system to document CAPA activities from stakeholders and global operations units* Monitor adherence to documented processes and procedures outlined in the QMS. Regularly audit processes to identify any deviations or non-compliance issues and take corrective actions as necessary* Participate in projects, process improvement initiatives & respond to stakeholder’s additional requests* Review complaint information and assess if the complaint is reportable to the appropriate regulatory bodies* Participation in tech/automation initiatives of the organization to improve the overall process of Vigilance* Consistently learns and adapts to different regulatory requirements and changes of different regions* Support establishment of quality specifications and standards and support the development of processes and standards.* Facilitate update of quality documentation, process mapping, reviewing processes and assisting with change initiatives* Prepare reports, analyze data to identify trends and opportunities for improvement related to the process* Escalate high risk incidents to management and PMV team* Respond to both Internal and External Audit enquiries in a timely manner and ensure follow-up on action Items to address any audit recommendations* Observe all health and safety policies and procedures and take all reasonable care that actions or omissions do not impact on the health and safety of others **Required Knowledge and Experience:** * Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline* Fluent English level* Minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or QA/RA role* MS Office Suite* At least 3 years of quality experience in the medical device industry or similar environment is an advantage* Good understanding of GDP and its implementation is required* Sound awareness and knowledge of ISO 13485 and its implementation* Complaint handling and Post Market Vigilance experience is an advantage* Strong experience and knowledge in regulatory requirements for adverse event reporting for approved devices is a great advantage.* Experience in writing comprehensive regulatory reports is an advantageExigences physiques du posteLes déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.