Quality 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
Quality Engineer ensures safety, reliability, quality and regulatory compliance to our products, i.e. complying with external and internal quality requirements. Additionally, duties include developing and implementing quality control processes, conducting risk assessment, and provides continuous support to Operations value stream in accordance with Coloplast Quality Management System.

Major areas of accountability:

• Develop and implement robust quality control processes to ensure safety and reliability of Coloplast products, including establishment of control plans, quality plans, as well as necessary local procedures
• Accountable for Device Master Record
• Create and maintain quality related documentation in alignment with corporate procedures
• Quality approval and release of products in ERP system
• Conduct thorough risk assessments and implement risk mitigation strategies to address potential hazards
• Handle non-conforming products incl. control of returned goods, reporting in NC system and handling of lot status in ERP (E1)
• Handling of the full CAPA process (risk assessment, deep root cause investigations, and evaluation of effectiveness of actions) as well as connect this to the market feedback (complaints process)
• Handling of Quality activities in Change Control system following local and corporate procedure
• Distribute product drawings to the production as well as manage controlled copies on the floor
• Ensure regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA etc).
• Actively participate in internal and external audits
• Identify opportunities for continuous improvements
• Maintain a good level of documentation and technical writing of quality processes, test results, prepare reports for Quality Management Reviews.
• Support implementation of new machines and item transfers with quality related tasks
• Implementation, training and follow up in relation to continuous improvements, including participation in root cause analysis sessions with relevant stakeholders
• Provide sparring and support to Global Operations incl. Global Quality and help improve the overall quality understanding and support of Lean activities.  
• Be ambassador for Quality department, provide guidance and training to members, as well as foster a quality culture for the site.

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 the positive EHS culture

Essential qualifications:

• Bachelor degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
• Minimum 3 years of experience in related positions
• Experience in manufacturing industries.
• English (minimum B1 level) reading, writing, and speaking in a conversational level
• Knowledge in Microsoft Office Package, E1, Veeva, Meridian, Cognos, SharePoint  

        
Prefer qualifications:

• English level B2
• Experience in medical industry
• Knowledge in Microsoft Office Package, E1, Veeva, Meridian, Cognos, SharePoint  

Required knowledge, skills & abilities:

• Proven expertise in MS Office and experience with quality systems (e.g., CAPA, NC, Change Control, Document Control)
• 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 as relating to documentation
• 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 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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