Senior Medical Devices Validation Specialist

hace 1 mes


San José, San José, Costa Rica Gsb A tiempo completo
Job Title: Senior Medical Devices Validation Specialist

We are seeking a skilled and experienced Senior Medical Devices Validation Specialist to join our team at Gsb in Costa Rica. This is an exciting opportunity for a motivated professional to lead the validation process of medical devices, ensuring compliance with regulatory requirements.

About the Role:

  • Lead cross-functional teams to develop strategies and solutions for medical device validation.
  • Guide the validation process, including protocol development, test reports, and onsite support during execution (IQ, OQ, PQ).
  • Draft validation strategies and technical documentation.
  • Qualify first articles, perform process capability studies, and ensure product design meets specifications.
  • Support change management and PLM tool implementation.
  • Prepare reports, supervise, coordinate, and revise technician work.
  • Ensure adherence to Health, Safety, Environmental practices and company policies.

Requirements:

  • 4+ years of experience in process/equipment validation and technical support in the Medical Device industry.
  • Advanced English language proficiency.

What We Offer:

  • Competitive estimated salary: $60,000 - $80,000 per annum based on qualifications and experience.
  • Training and certification opportunities.
  • A 9-month project with possible extension.

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



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