Area Quality Specialist

healthcare; Bogotá ciudad; Hybrid; COP 90,000,000 - 130,000,000; Full time

Job summary

Solventum busca un Especialista de Calidad de Área para unirse al equipo en Colombia. Reportarás al Director Técnico y coordinarás la gestión de calidad para asegurar cumplimiento normativo y mejora continua en operaciones.

Entre tus funciones estará gestionar ENOVIA, analizar KPIs de calidad, liderar CAPA y auditorías, y apoyar liberaciones de producto, cambios y documentación de CoAs. Se valora experiencia regulatoria y entorno de dispositivos médicos.

Qualifications

• Licenciatura en Farmacia u otra disciplina relacionada.
• Al menos 3 años gestionando QMS y GDP en dispositivos médicos y/o farmacéuticos.
• Inglés intermedio-avanzado para entorno global.
• Conocimiento de regulaciones de dispositivos médicos y farmacéuticas.
• Experiencia en auditorías internas, evaluaciones de riesgos, CAPA, cambios e inspecciones.

Responsibilities

• Gestionar y gobernar el sistema de control de documentos ENOVIA.
• Monitorear KPIs de calidad y favorecer la mejora continua.
• Liderar investigaciones y mantener CAPAs efectivas.
• Realizar evaluaciones de riesgos anuales y apoyar auditorías internas y externas.
• Impartir formación y programas de cualificación en QMS.
• Colaborar con el Director Técnico para cumplir requisitos regulatorios.
• Apoyar liberación de productos y gestión de CoAs.
• Gestionar cambios y controles documentales.
• Ser respaldo del Director Técnico cuando sea necesario.
• Cumplir responsabilidades adicionales según prioridades.

Skills

QMS

GDP

Internal audits

Risk assessment

CAPA management

Regulatory inspections

Regulatory knowledge

English proficiency

Education

Pharmacy degree

Job description

Gracias por tu interés en unirte a Solventum. Solventum es una empresa nueva en el ámbito de salud, pero con una sólida experiencia en la resolución de desafíos que transforman vidas y fortalecen el trabajo de los profesionales de la salud. En Solventum, las personas son el centro de cada innovación que desarrollamos. Con empatía, conocimiento y criterio clínico, trabajamos en conjunto con los líderes más destacados del sector para enfrentar los retos más complejos de nuestros clientes. Mientras continuamos actualizando nuestra Página de Carreras y los materiales dirigidos a los postulantes, es posible que algunos documentos aún muestren la marca anterior. Ten en cuenta que todas las oportunidades laborales publicadas pertenecen a Solventum, y que la Política de Privacidad mencionada https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/a cualquier información personal que proporciones. Al igual que en 3M, en Solventum se brinda igualdad de oportunidades a todos los candidatos calificados, sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, origen nacional, discapacidad o estatus como veterano protegido. En Solventum, desarrollamos soluciones innovadoras para enfrentar los retos más complejos de nuestros clientes, liderando avances en salud mediante la combinación de ciencia médica, de materiales y de datos. Nuestro propósito es mejorar la vida de los pacientes y apoyar a los profesionales de la salud para que se desempeñen de la mejor manera posible.

Job Description:

Area Quality Specialist

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

As an Area Quality Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Manage and govern the company’s document control system (ENOVIA), ensuring review step compliance with local requirements.
• Monitor, analyze, and drive performance against key quality KPIs, ensuring timely disposition and continuous improvement.
• Lead cross-functional investigations and manage the development, implementation, and effectiveness monitoring of Corrective and Preventive Actions (CAPAs).
• Conduct annual site risk assessments, develop, execute, and oversee internal audit and self-inspection programs. Supports external audits per Technical Director instructions and global procedures.
• Deliver training and qualification programs to employees on QMS requirements and quality processes.
• Partner with the Technical Director to ensure ongoing compliance with applicable regulatory, quality, and operational requirements.
• Support product release activities, including oversight of Certificates of Analysis (CoAs) and related quality documentation.
• Manage change control processes, including documentation, impact assessment, implementation, and effectiveness tracking.
• Act as the designated backup for the Technical Director, ensuring uninterrupted oversight of quality and regulatory compliance activities when required.
• Undertake additional responsibilities as assigned by management to support organizational priorities and continuous improvement initiatives.

Your Skills and Expertise

To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications:

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Healthcare, or a related field (completed and verified prior to start date).
• Minimum of three (3) years of experience maintaining Quality Management Systems (QMS) and Good Distribution Practices (GDP) within Medical Devices and/or Pharmaceutical environments.
• Intermediate to advanced English proficiency, with the ability to communicate effectively in a global environment.
• Strong knowledge of Medical Device and Pharmaceutical regulations, including Good Storage, Distribution, and Transportation Practices.
• Experience conducting internal audits, risk assessments, CAPA management, change controls, and regulatory inspections.

Additional qualifications that could help you succeed even further in this role include:

• Statistics and data analysis for quality performance monitoring and continuous improvement.
• Experience in Regulatory Affairs within regulated healthcare industries.
• Knowledge of Integrated Management Systems (IMS), Good Manufacturing Practices (GMP), and Corrective and Preventive Actions (CAPA).
• Familiarity with Colombian regulatory requirements for Medical Devices and Pharmaceuticals.

Work location: Hybrid (Solventum office and at the 3PL in Cundinamarca)

Travel: May include up to 10% in country

Supporting Your Well-being

Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

Solventum es un empleador que ofrece las mismas oportunidades. Solventum no discriminará a ningún solicitante de empleo por razones de raza, color, edad, religión, sexo, orientación sexual, identidad o expresión de género, origen nacional, discapacidad o estado de veterano.

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

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