Product Quality Engineer 1 CR (Temporary 12 months)
H
Hologic
📍 Alajuela, Costa Rica, Costa Rica
Job Description
Product Quality Engineer 1 CR (Temporary 12 months)
Alajuela, Costa Rica
+ **Education / Educación:**
+ University bachelor’s degree in engineering or similar.
+ **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):**
+ Familiarity with FDA Quality System Regulations, specifically Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management
+ Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
+ Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
+ Familiarity with verification and validation requirements for a regulated product
+ Familiarity with requirements analysis, including development of testable and measurable specifications
+ **Languages** **** **required for the position (Desirable) / Idiomas requeridos para el puesto ...
Alajuela, Costa Rica
+ **Education / Educación:**
+ University bachelor’s degree in engineering or similar.
+ **Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):**
+ Familiarity with FDA Quality System Regulations, specifically Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14970, Risk Management
+ Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
+ Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
+ Familiarity with verification and validation requirements for a regulated product
+ Familiarity with requirements analysis, including development of testable and measurable specifications
+ **Languages** **** **required for the position (Desirable) / Idiomas requeridos para el puesto ...