Quality Assurance Engineer 2 (alajuela, Costa Rica)

Smith & Nephew

Alajuela, Costa Rica
**
Quality system compliance
Design verification and validation
Risk management documentation
** Smith & Nephew is seeking a Quality Assurance Engineer 2 in Alajuela, Costa Rica, focusing on ENT technologies. The role involves implementing and supporting quality systems, ensuring compliance with medical device regulations, and collaborating with project teams to maintain product reliability and safety. **

Job Summary

  • This position will implement, support, and sustain elements of Smith & Nephew’s Quality System through design testing, protocol/report generation, training, and technical support.
  • The Quality Assurance Engineer determines methods, techniques, and evaluation criteria for medical devices and serves as a key resource for ISO, EN, MDD, MDR and QMSR requirements.
  • Smith & Nephew is committed to creating the greatest good for society and invests strongly in its people and the patients it serves.

Matching Summary

Match Score: 75

** Smith & Nephew is seeking a Quality Assurance Engineer 2 in Alajuela, Costa Rica, focusing on ENT technologies. The role involves implementing and supporting quality systems, ensuring compliance with medical device regulations, and collaborating with project teams to maintain product reliability and safety. **

Skills & Requirements

Must-have

  • Quality System Compliance
  • Design Verification and Validation
  • Risk Management Documentation
  • Medical Device Standards Compliance
  • CAPA/NC/Internal Audit Support

Nice-to-have

  • Guidance to project teams
  • Supplier qualification expertise
  • Continuous improvement activities

Key Requirements

  • +2 years of experience in regulated industries
  • Proficiency in PLM systems
  • Bachelor’s degree in Engineering or related field
  • Excellent English proficiency

Work Rights

Not specified

Tailored Resume

Cover Letter