Senior Medical Devices Validation Specialist
hace 1 semana
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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