Validation Quality Engineer – Innovation Value Stream
Coloplast
full-time
Posted on:
Location Type: Office
Location: Cartago • 🇨🇷 Costa Rica
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Leads the IVS project quality and validation activities, providing technical direction
- Developing and implementing quality control processes
- Performing risk assessments
- Supporting Operations in alignment with the Coloplast Quality Management System
- Executing and maintaining processes, equipment, software, and test method validations
Requirements
- 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+
- 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
Benefits
- Oportunidades de aprendizaje y desarrollo
- Programas de bienestar
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality control processesrisk assessmentstest method validationsstatistical techniquesJMPMinitabquality management systemISO 13485ISO 9001validation
Soft skills
technical directioncommunicationleadershiporganizational skillsproblem-solvingcollaborationadaptabilityattention to detailanalytical thinkingtime management
Certifications
Quality EngineerValidation EngineerNPI engineer