Validation Specialist

3 tygodni temu

Kraków, Lesser Poland Human4Human Recruitment Pełny etat
Senior Validation Engineer

As a Senior Validation Engineer at Human4Human Recruitment, you will be responsible for ensuring the highest quality standards in our medical devices. Your expertise in validation engineering will be crucial in driving continuous improvement and shaping the future of our products.

Key Responsibilities:

  • Collaborate with cross-functional teams to develop and implement quality assurance processes.
  • Evaluate the cause and effect of defects, identifying trends in titanium machining processes and product quality.
  • Provide technical expertise for projects, employing tools such as FMEA, risk mitigation, plant validations, DOE, and other experiments.
  • Apply a working knowledge of Validations, IQ, OQ, PQ, SIMS, and DOE's, contributing to robust quality assurance processes.
  • Review vendor documents, identifying gaps, and collaborating to close them.
  • Approve and assist in the launch of products, coordinating with vendors for PPAP documentation.

Requirements:

  • Proven track record and hands-on experience in validations, IQ, OQ, PQ, SIMS, and DOE's.
  • Fluency in English.
  • Strong understanding and knowledge of machining processes, including defect remediation activities.
  • Good understanding and experience in Geometric Dimensioning and Tolerancing (GD&T) and complex drawing interpretation.
  • Hands-on experience in creating PFMEA, Process Control Plans, and coordinating with vendors for PPAP documentation.
  • Proven track record of supporting and driving continuous improvement activities in a production environment.
  • Effective coordination and communication skills to work with internal and external teams, ensuring successful project outcomes.

What We Offer:

  • Your salary will be highly correlated with your skills and mindset: from 16.000 up to 20.000+ gross PLN.
  • Participating in the newest medical devices, classified products, and solutions.
  • Exciting and Challenging Projects in Healthcare.
  • Collaborative and Dynamic Environment in a global company.
  • Being part of an ambitious company with a lot of growth opportunities awarded with Great Place to Work 2023.
  • Playing a crucial role in the development team.
  • Working in an agile culture with exposure to an international environment.

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