IVS Quality 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.

Job function summary

The IVS Project Quality Engineer leads and manages QA activities for IVS projects, ensuring compliance with international standards and the Coloplast Management System. It oversees documentation, training, risk assessments, validations, change control, and quality deliverables throughout the project lifecycle. The position supports IVS projects execution and maintaining alignment with key stakeholders. 

Major areas of accountability:

Project & QA Leadership
•    Lead, manage, and support QA activities for IVS projects at the CAR site, including initiatives related to the Global Operation Plan and CAR QA.
•    Define scope and analyze QA project requirements within CAR.
•    Ensure successful project execution within defined scope, timelines, and quality expectations.
•    Participate in regular meetings and provide project updates to relevant stakeholders.
•    Manage, take the lead of project and CAPA related QA IVS activities at CAR site, including root cause analysis
•    Monitor and report QA KPIs, risks, and issues to the Head of Quality and other stakeholders.
•    Identify opportunities for continuous improvement in quality processes and project execution.
•    QA site IVS roles by RACI

Regulatory & Quality Compliance

•    Manage and control the QA projects in accordance with regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA, etc) and country specific medical device regulations and the Coloplast Management System.
•    Actively participate in internal and external audits.

Documentation, Processes & Training

•    Manage and maintain QA documentation, including creating, updating, implementing, and training related to IVS projects and requirements for Quality Management Review. 
•    Update and control key technical documentation, such as DMR content, quality and control plans, specifications, test methods, and other regulatory-related documents. 
•    Manage and execute the process risk assessments, including creating or updating process RAs and ensuring all risks are properly mitigated. 
•    Manage QA tasks within the Change Control system, in compliance with local and corporate procedures 

Validations & Technical Quality Activities
•    Provide quality oversight by reviewing, approving, and monitoring all validation activities—across processes, equipment, software, and test methods—to ensure full alignment with procedures and regulatory requirements.
•    Perform repeated or updated validations when changes occur in DIO, Product RA, or regulatory updates, addressing new requirements, risk score changes, and validation gaps. 
•    Investigate abnormal test results and resolve process issues through root cause analysis, corrective actions, and effectiveness checks.

Risk Management
•    Lead and maintain comprehensive risk management activities, including conducting and updating process/product risk assessments, ensuring proper identification, evaluation, mitigation, and documentation of risks, and supporting specification-setting for legacy products lacking defined specifications. 
•    Report on QA performance and risk status to key stakeholders, providing clear updates on QA KPIs, risks, and issues, and implementing mitigation strategies to address potential hazards.

Design Verification & Documentation Control
•    Take samples for design verification and coordinate testing with production/QA lab.
•     Manage and update all quality documentation and technical records— including DMRs, quality/control plans, and QA documents, while ensuring clear, accurate reporting and technical writing for IVS projects and QMR.

Team Support & Decision Making
•    Substitute QA engineers when required and aligned with training completion and non-conforming product and events handling related to IVS projects.
•    Make decisions on behalf of QA engineers according to the complete training plan and the job description and responsibilities of QA engineers.

Responsible for:
•    Support the positive EHS culture
•    Take responsibility for those safety aspects identified for the given position
•    Performing their job in compliance with the guidelines given
•    Drawing attention to the manager to any difficulties in understanding or following the guidelines
•    Creating and managing CAPAs, NCs, CRs, SOPs, CAPA owner
•    Quarantining, releasing, scrapping raw materials, intermediates, finish goods according to the completed training plan – Handling NCs, E1 system from QA point of view

Essential qualifications:
•    Bachelor’s degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
•    Minimum 5 years of experience in medical device manufacturing with a deep knowledge of quality assurance methodologies and standards. 
•    English (minimum B2 level) reading, writing, and speaking in a conversational level
•    Excellent numerical skills and understanding of data analysis. 
•    Ability to interact professionally with all organizational levels across sites
•    Ability to manage competing priorities in a fast-paced environment
•    Able to travel approximately 20-25 days per year. 

Prefer qualifications:
•    Experience in innovation projects implementation
•    Knowledge of MS Project or other necessary project management tools. 
•    Master's degree in project management or PM Certification. 

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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