Quality Systems Specialist.

hace 4 semanas

Bogotá, Colombia Medtronic A tiempo completo
Careers that Change Lives

The Quality Systems Specialist will support LATAM (Latin America) Post Market Vigilance activities related to Product Complaint Handling. The successful candidate(s) will be focusing on Reportability Decisions and Regulatory Reporting processes in Center-led Complaint Handling in LATAM.

A Day in the Life

·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.

·Work within and actively promote Medtronic’s Mission, corporate strategies, policies, procedures and Code of Conduct.

·Other duties as assigned by the supervisor/manager.

Must haves Bachelor's Degree Required in Medical, Biological Science, Pharmaceutical Science, Engineering, or any related discipline With minimum of 2 to 3 years of experience in Post Market Surveillance, Vigilance or Quality/Regulatory Affairs or quality systems areas. Fluent in English level. Computer literacy including sound knowledge of the MS Office Suite or software. Good understanding of GDP and its implementation is required. Mission Values: Consciously works to bring the Mission alive External Focus: Customer responsive, competitive and market driven, leads and supports Change Clear Thinking: Translates complexity into simplicity, articulates crisply and clearly Driven to Win: Passionate and driven, makes tough decisions in difficult situations Inspires Others: Authentic and sets a vision to inspire performance and engage others Executes: Takes accountability for and consistently delivers consistent decisions, actions, and results Boundaryless: Breaks down silos, collaborates across organizational boundaries Global: Culturally agile, strives to understand diverse market needs and responds with creative and effective solutions Integrity and Compliance: Practice the highest ethical standards and integrity in every aspect of my job.  Team player. Great communication skills. Nice to haves
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 advantage. Proven experience as supervisor or relevant role is a plus. Good understanding of GDP and its implementation is required. Knowledge of ISO 13485 and its implementation will be an added advantage. Previous experience with pharma, medical devices or related fields. Sound working knowledge of ISO13485 is an advantage. Experience in handling/executing Field corrective action is an advantage.

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