Validation Quality Engineer

Job function summary

Leads the IVS project quality and validation activities, providing technical direction, ensuring alignment with quality and regulatory standards, and driving successful project execution across cross‑functional teams, ensures product safety, reliability, and compliance with internal and external quality requirements. The role includes developing and implementing quality control processes, performing risk assessments, and supporting Operations in alignment with the Coloplast Quality Management System. It also involves executing and maintaining processes, equipment, software, and test method validations throughout their lifecycle.

Major areas of accountability

Validation & Test Method Activities

• Issuing, completing and approving the full validation lifecycle for processes, equipment, software, instruments, and test methods ( Performing Installation Qualification /Operation Qualification).
• Develop validation strategies and maintain all validation documentation (protocols, reports, deviations, data records).
• Validate Innovation Value Stream test methods for continuous and attribute data and support design verification testing such as taking out samples and coordinating with production and QA areas.
• Perform statistical analysis to ensure process and test method robustness and assess any abnormal result and validation troubleshooting by RCA tools.
• Conduct and update process risk assessments due to new or update of product risks assessment /Design input output, specification, test methods and validation related updates.
• Perform QA and validation activities for IVS projects, ensuring delivery within scope, schedule, and regulatory expectations.
• Manage change control tasks related to process validation, software validation, risk assessments, instruction and training and quality action.

Quality Assurance & Risk Management

• Develop and maintain quality control processes, including control plans, quality plans, Device Master Record content and other quality and regulatory related documentation.
• Investigate abnormal test results, troubleshoot process issues, and support CAPA and Non-conformance activities (root cause analysis, corrective actions, effectiveness checks).
• Manage non conformities, returned goods, and product release in the ERP system.
• Ensure compliance with ISO 13485, MDSAP, MDR, FDA, and corporate QMS requirements

Documentation, Training & Compliance

• Train stakeholders on QA processes, validation requirements, and regulatory expectations.Manage controlled documents, including product drawings and controlled copies on the production floor.
• Prepare quality documentation and reports for audits and management reviews.
• Support EHS culture and comply with internal and external work instructions.

Audits, Continuous Improvement & Collaboration

• Participate in internal and external audits and ensure readiness of validation and QA documentation.
• Collaborate with cross functional teams and participate in regular stakeholder meetings.
• Executes tasks to the ordinance of the superior or upon his initiative, which are not listed in the job description, but based on the job it is part of his job, or in case of emergency or if it is additional part of his job.

Responsible for: 

• Performing their job in compliance with the guidelines given
• Drawing attention to the manager to any difficulties in understanding or following the guidelines
• Drawing attention to inefficiency of the system
• Take responsibility for those safety aspects identified for the given position
• Support EHS positive culture
• Ensuring successful completion of project within scope and schedule
• Performing with focus in the Corporate and department KPIs

Essential qualifications

• Bach. degree in an Engineering field, such industrial, electrical, mechanical, etc.
• Understanding and Knowledge of the quality system standards ISO 13485 and ISO 9001.
• Experience in regulated industries such MDSAP, MDR, FDA, and corporate QMS requirements (e.g., medical device industry).
• Experience with Microsoft Office package (Word, Excel, PowerPoint, Outlook).
• Knowledge in statistical techniques and software applications such as JMP, Minitab, etc.
• Min. 6-10 years of experience in quality, innovation and validation roles.
• Fluent in both spoken and written English 
• B2+ English level 

Prefer qualifications

• Quality Engineer, Validation Engineer, or NPI engineer certifications.
• Mobile; capacity to travel abroad to receive training and support transfer activities 
• C1 English level

Required knowledge, skills & abilities

• Proven expertise in MS Office and experience with quality systems (e.g., CAPA, NC, Change Control, Document Control, Validation documentation lifecycle)
• Excellent written and verbal communication skills including influencing and relationship management skills
• Strong problem-solving and critical thinking skills
• Excellent knowledge of medical or pharmaceutical regulations.
• Strict attention to detail
• Ability to interact professionally with all organizational levels across sites
• Ability to manage competing priorities in a fast-paced environment

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 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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