Medical Device Validation Expert

3 semanas atrás


Braga, Braga, Portugal Multipessoal Tempo inteiro

Pursuing an ambitious growth agenda, Coloplast develops and markets products that simplify life for individuals with intimate healthcare needs. With a presence in over 143 countries, they are one of the world's leading medical device companies.

Role Overview

We are seeking a highly skilled Medical Device Validation Expert to play a pivotal role in ensuring product quality as a partner in process validation. As a key compliance component and gatekeeper for starting production at our new site, this position is crucial to our success.

The ideal candidate will support and foster a quality culture across the site, participate in and lead validations, approve validation-related documentation, train and guide the organization on site, and identify and facilitate mitigation discussions for process risks.

Key Responsibilities:

  • Support and promote quality culture across the site.
  • Participate in and lead validations.
  • Approve validation-related documentation.
  • Train and guide the organization on site.
  • Identify and facilitate mitigation discussions for process risks.

Requirements:

  • A relevant academic background (B.Sc. or higher).
  • Minimum 2 years of experience as a Validation Engineer / Test Engineer or similar within a production environment.
  • Solid understanding of validation and quality principles (GDP and GMP, etc.).
  • Knowledge of process validation and risk assessment.
  • Project knowledge and experience.
  • Holistic understanding of end-to-end production.
  • Fluent in spoken and written English (other languages are a plus).

What We Offer:

  • An attractive salary around €55000 - €65000 per year, depending on experience.
  • Competitive benefits package, including opportunities for professional development and advancement.
  • The chance to join a renowned multinational in the medical devices sector and shape the future of their brand-new manufacturing unit in Portugal.


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