Quality Assurance Engineer 2 (alajuela, Costa Rica)
Smith+Nephew
Alajuela, Costa Rica
On-site
Design testing and protocol generation
Iso, en, mdd, mdr and qmsr requirements
Product specifications and standards compliance
Smith+Nephew is seeking a Quality Assurance Engineer 2 in Alajuela, Costa Rica, to support their expanding ENT technology portfolio. The role involves implementing quality systems, ensuring compliance with medical device regulations, and providing expertise to project teams
Job Summary
This role is focused on the expanding portfolio of ENT (Ear, Nose, and Throat) technologies at Smith+Nephew, which includes advanced high frequency electrosurgical devices and systems, as well as small, handheld electronic devices used for innovative medical treatments and drug delivery.
The Quality Assurance Engineer determines methods, techniques, and evaluation criteria for medical devices and serves as a key resource for regulatory requirements.
Smith+Nephew offers a comprehensive benefits package including stock purchase program, health insurance, and training opportunities.
Matching Summary
Match Score: 85
Smith+Nephew is seeking a Quality Assurance Engineer 2 in Alajuela, Costa Rica, to support their expanding ENT technology portfolio. The role involves implementing quality systems, ensuring compliance with medical device regulations, and providing expertise to project teams.
Skills & Requirements
Must-have
Design testing and protocol generation
ISO, EN, MDD, MDR and QMSR requirements
Product specifications and standards compliance
Risk management documentation
Nice-to-have
Guidance to technicians and operators
Continuous improvement activities
Key Requirements
Bachelor’s degree in Engineering or related field
+2 years of professional experience in regulated medical/healthcare industries