Quality Engineer
hace 3 semanas
About the Role:
Coloplast is seeking a Quality Engineer to join our team in Cartago, Costa Rica. This is a permanent-full time position that offers a range of benefits, including medical insurance, association, gym, cafeteria subsidy, free transportation, and more.
Main Responsibilities:
- Develop and implement robust quality control processes to ensure safety and reliability of Coloplast products.
- Handle non-conforming products, including 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.
- Handle the full CAPA process, including risk assessment, deep root cause investigations, and evaluation of effectiveness of actions.
- Ensure regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA, etc.).
- Support implementation of new machines and item transfers with quality-related tasks.
Requirements:
- 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.
About Coloplast:
Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfill 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.
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