Drug Safety Operations Manager

Buscojobs México; Veracruz; Presencial; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

Una empresa de dispositivos médicos busca un colaborador técnico que apoye la gestión de riesgos y la mejora de calidad en productos y procesos. Se requiere un título en ingeniería y habilidad para comunicarse en inglés. El candidato ideal tiene experiencia en el sector y estará involucrado en proyectos de mejora de calidad. Este puesto es presencial y puede incluir un 10% de viajes.

Formación

• Experiencia previa en una empresa de dispositivos médicos (1 a 3 años).
• Capacidad de analizar profundamente para asegurar la mejor solución.
• Conocimiento de herramientas de SPC y Six Sigma.

Responsabilidades

• Realizar análisis de riesgo para productos, tanto nuevos como existentes.
• Actualizar documentación de riesgo utilizando datos de revisiones post-mercado.
• Mejorar procesos de calidad según sea necesario.

Conocimientos

Navegación en sistemas de calidad y cumplimiento

Conocimiento básico de requisitos CFR 21 820/ISO 13485

Conocimientos de controles de diseño y cambios

Análisis de datos en Excel

Funcionalidad básica en PowerPoint

Educación

Licenciatura en ingeniería eléctrica, mecánica o sistemas

Herramientas

TrackWise

Descripción del empleo

Overview

As Intuitive’s da Vinci Surgical System and other medical devices become adopted by an increasing population of hospitals, surgeons and patients, we are building a focused team to drive reliability, quality, and safety to ever-better levels. This focus applies to product in use, product in manufacturing, and product in design. Help us powerfully drive our quality mission in our young and growing company by bringing your hands-on experience in solving tough engineering problems, your fascination with complex electro-mechanical devices, and your passion for the best practices to design, monitor, and improve product and process. Intuitive seeks a strong technical contributor who can review and process escalation activities, review, and update risk management file documents, and identify key opportunities for product improvement. You will not abide “process red tape”, instead passionately seeking the most efficient way to build in product quality.

Essential Job Duties

90% Risk Management document support, 10% quality advocacy and project management.

• Risk Management
  • Participate in Risk Analyses for new and existing products, including review of both hardware and software.
  • Using data from Post Market reviews, update risk documentation as needed, following confirmations with Project QEs and Design Engineering.
  • Work with Design Engineering to maintain tracing of risk to requirement to test.
  • Work with Manufacturing Engineering on process risk documents
  • Participate in review of technical and quality information for regulatory submissions.
• Quality Process Improvements
  • As needed, participate in Quality process improvement projects (CAPA, Process NonConformance, Quality Plans, other process improvements)

Qualifications

Required Skills and Experience (Specific skills, knowledge, and experience that an individual must possess in order to successfully perform in job)

• Able to navigate quality and compliance system with minimal oversight on individual projects.
• Basic knowledge of CFR 21 820/ ISO 13485 requirements for making process or design changes.
• Understands product risks, able to work with design and quality engineers to update risk documents.
• Understands Design Controls, Change Controls, Product, and Engineering Processes.
• Uses data to quantitatively communicate problem or issue.
• Basic functionality in PowerPoint
• Understands typical Excel data analysis operations (bonus for Vlookup, Pivot table and pivot chart functions).
• Works with Peers to understand and document issues.
• Operates with minimal oversight for basic problems or assignments, and escalates appropriately for issues requiring clarification.

Required Education and Training

Education and Training (As applicable - Specific education and training that an individual must possess in order to successfully perform in job)

• English Level: High (Good writing and speaking skills in English)
• Education: Bachelor degree in electrical, mechanical or system engineering, life sciences, mathematics, or physics. Advanced degree is a bonus.

Working Conditions

No special physical requirements. Onsite. Travel not to exceed 10%.

Preferred Skills and Experience

(As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)

• Preferred:
• 1 to 3 years of working experience in a medical device company
• Experience with Agile/ACCS, TrackWise, or other electronic documentation systems (desired)
• Participation in internal / external audits conducted
• Aware of SPC & Six Sigma methodology and tools (e.g. uses DMAIC process and basic tools such as 5 Why's, control charts, fishbone diagram).

Personality Requirements

• Able to cope with changes and uncertainties; and handle associated risks comfortably.
• Ask questions and don’t stop at the first answer. Analyze deeply to ensure the solution is the most effective solution.
• Brings unpleasant facts to discussion, does not hold back information.
• Driven by results. Fully supports team decision, even if he/she disagrees with the decision.
• Enjoys working hard and learning when opportunities arise.
• Gives credit to others for success, and does not blame others for his/her mistakes. Doesn’t misrepresent him/herself for personal gain or protection.
• Listens and respects others. Demonstrates constructive work relationship with others in the organization.
• Offers suggestions for doing things differently, brings measurable evidence to support each decision. Able to breakdown complex issues into simplified task.
• Sets priority and manages time wisely, capable of identifying the critical issues from the trivial issues. Sets individual goals aligning with the team goal.
• Understands that the real success is the success of the whole team.

Additional Information

Intuitive es un empleador que brinda igualdad de oportunidades de empleo. Proporcionamos igualdad de oportunidades de empleo a todos los solicitantes y empleados cualificados, y prohibimos cualquier tipo de discriminación y acoso, independientemente de su raza, sexo, condición de embarazo, orientación sexual, identidad de género, origen nacional, color, edad, religión, condición de veterano protegido o de discapacidad, información genética o cualquier otra condición protegida por las leyes federales, estatales o locales aplicables.

Shift: Day