Validation Engineer

hace 2 semanas


San José, San José, Costa Rica GSB A tiempo completo
About the job

Exciting opportunity at a renowned international company for a Validation Engineer experienced in the Medical Devices sector. (9-month project with the chance of extension)

Technical/Functional Skills
  • Knowledge of Medical Equipment manufacturing processes
  • GMP (Good Manufacturing Practices) & ISO 9000 standards and regulatory affairs
  • Ability to specify & qualify Assembly, Tooling, Gage equipment, and Fixture equipment
  • Expertise in Process validation, Statistical process control, Product design & DFMA, Plastic & metallic materials & processing, and Applied Statistics
  • Proficiency in drawing software systems like AutoCAD and Solidworks
  • Interpretation of engineering drawings e.g., GD&T (Geometric Dimensioning & Tolerancing)
  • Understanding of productive processes
  • Collaborative team player with the capability to work under pressure
Responsibilities
  • Conduct meetings to strategize with a cross-functional team
  • Guide Validation process, lead protocol drafting and review, provide onsite support during validations
  • Develop Validation Strategy, including TMV's
  • Qualify first articles, conduct process capability studies, and support change management activities
  • Prepare project reports and supervise technicians
  • Ensure adherence to Health, Safety, and Environmental practices
  • Communicate business-related matters to upper management
  • Ensure compliance with regulations and company policies
Requirements
  • 4+ years of experience in process/equipment validation & technical support preferably in the Medical Device industry
  • Advanced proficiency in English
Benefits

Professional development opportunities through courses and certifications

9-month project with potential extension

Location: Saret Industrial Park, Rio Segundo, Alajuela, Costa Rica

Onsite, Business Hours

Job Type: Full-time

Languages
  • English (Mandatory)

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