Location:
Cartago, Costa Rica, CR

Job Family: Quality Assurance
Country/Region: Costa Rica

This is a permanent-full time position to work in our Cartago site, located in Zona Franca La Lima. 2 day of remote work per month, medical insurance, asociation, gym, cafeteria subsidy, free transportation and other, are part of our benefits package

Our 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
Handle non-conforming products incl. control of returned goods, reporting in NC system and handling of lot status in ERP
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
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
Ensure regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA etc).
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.

Essential qualifications

Minimum bachelor’s degree in Chemical or Materials Engineering, or equivalent, or minimum 3 years of relevant experience within medical device manufacturing.
1 year of experience within medical device manufacturing
English (minimum B2 level) reading, writing, and speaking in a conversational level

Preferred qualifications

Microsoft Office Package, ERP Systems, non-conforming documentation system

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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