Quality IVS Projects Engineer

This is a permanent position to work in our Cartago site, located in Zona Franca La Lima. Medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package.

QA IVS projects Engineer site.

This role ensures regulatory compliance, supports validations, strengthens technical documentation, and enables risk‑based decisions that drive future product and process improvements. This role offers the opportunity to drive quality excellence within high‑impact innovation projects and contribute to processes that directly affect patient safety and product performance.

Main responsibilities 

• Defines project requirements, coordinates execution, and ensures that all deliverables meet regulatory, quality, and timeline expectations.
• Ensures full compliance of project activities with global medical device regulations—including MDSAP, MDR, ISO 13485, and FDA requirements—as well as the Coloplast Management System.
• Supports internal and external audits through expert knowledge and documentation readiness.
• Oversee the creation, maintenance, and training of quality documentation for IVS projects. Responsibilities include managing DMRs, specifications, test methods, risk assessments, and change control activities in accordance with corporate and local requirements.
• Provides oversight for validations related to processes, equipment, software, and test methods, ensuring alignment with regulatory and procedural standards. The role approves protocols and reassesses validations as needed due to risk, regulatory, or process changes, and leads investigations to resolve abnormal test results.
• Owns non-conforming events and CAPAs related to IVS projects.
• Leads process and product risk management activities by identifying, evaluating, mitigating, and documenting risks. The engineer also supports the definition of specifications for legacy products and communicates risk status and KPIs to key stakeholders.
• Coordinates sample collection for design verification testing and ensure proper testing execution through Production and the QA Laboratory.
• The role maintains accurate and compliant quality documentation for IVS projects and supports Quality Management Review (QMR) requirements.
• The engineer provides backup support to QA team members when necessary and makes quality‑related decisions within the authorized training scope, ensuring continuity of quality operations across the site.

Required Qualifications

• Bachelor’s degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field.
• A minimum of 5 years of experience in medical device manufacturing with strong QA expertise.
• English proficiency at B2 level or higher.
• Strong analytical and data interpretation skills.
• Demonstrated ability to work effectively with cross‑functional and cross‑site teams.
• Ability to manage multiple priorities in a fast‑paced environment.
• Availability to travel approximately 20–25 days per year.

Preferred Qualifications

• Experience leading or supporting innovation projects.
• Knowledge of MS Project or similar project management tools.
• Master’s degree in project management or a professional certification (e.g., PMP).

Con unos ambiciosos planes de crecimiento, Coloplast desarrolla y comercializa productos y servicios que hacen la vida más fácil a aquellas personas con necesidades de cuidados sanitarios especiales. Tenemos más de 16 000 empleados y nuestros productos están disponibles en más de 143 países. Somos una de las empresas líderes de dispositivos médicos a nivel mundial. Constantemente buscamos nuevas formas de hacer crecer el negocio : exploramos, aprendemos y buscamos nuevas formas de hacer las cosas.

Coloplast se compromete a ser una organización inclusiva, donde las diferencias son bienvenidas, las personas desarrollan su potencial y tienen un fuerte sentido de pertenencia debido a  _ no a pesar de_ sus diferencias. Por ello animamos a todos los candidatos idóneos y cualificados a presentar su candidatura independientemente de su sexo, edad, raza, nacionalidad, etnia, orientación sexual, creencia religiosa o capacidad física.

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